Ballooned ventilation tube cleaning device

ABSTRACT

A cleaning device, system and method for use with an ETT or tracheostomy ventilation tube  60 , a ventilator machine  900 , a source(s)  602  of fluid (for example, pressurized or unpressurized) and a source(s) of suctioning  603  is disclosed. In some embodiments, the cleaning device is useful for cleaning an inner surface of the ventilation tube  60  and/or for preventing or hindering the accumulation of biofilm thereon. In some embodiments, it is possible to clean biofilm or any other material on the inner surface  201  by delivering fluid into an interior of the ventilation tube, wiping the tube interior with a width-expanded wiping element (e.g. an inflated balloon) by longitudinal motion of the wiping element, and suctioning material out of the ventilation tube ventilation tube.

This application is a continuation of U.S. application Ser. No.14/008,558, issued as U.S. Pat. No. 10,322,253, which is a nationalphase of, and claims priority from, PCT Application No. PCT/IB12/51532,filed on Mar. 29, 2012, which claims priority from U.S. ProvisionalPatent Application No. 61/613,408, filed Mar. 20, 2012, and claimspriority from U.S. Provisional Patent Application No. 61/609,763, filedMar. 12, 2012, and claims priority from U.S. Provisional PatentApplication No. 61/603,344, filed Feb. 26, 2012, and claims priorityfrom U.S. Provisional Patent Application No. 61/603,340, filed Feb. 26,2012, and claims priority from U.S. Provisional Patent Application No.61/560,385, filed Nov. 16, 2011, and claims priority from U.S.Provisional Patent Application No. 61/539,998, filed Sep. 28, 2011, andclaims priority from U.S. Provisional Patent Application No. 61/527,658,filed Aug. 26, 2011, and claims priority from U.S. Provisional PatentApplication No. 61/496,019, filed Jun. 12, 2011, and claims priorityfrom U.S. Provisional Patent Application No. 61/483,699, filed May 8,2011, and claims priority from U.S. Provisional Patent Application No.61/473,790, filed Apr. 10, 2011, and claims priority from U.S.Provisional Patent Application No. 61/468,990, filed Mar. 29, 2011, andwhich claims priority from GB Application No. 1119794.4, filed Nov. 16,2011, and claims priority from GB Application No. 1116735.0, filed Sep.28, 2011, and claims priority from PL Application No. PL396436, filedSep. 26, 2011, the disclosures of which are hereby incorporated byreference in their entireties.

FIELD

Embodiments of present invention relates to devices, systems and methodsof cleaning an interior of a ventilation tube and/or hindering thebuild-up of biofilm therein.

BACKGROUND AND RELATED ART References Cited

US patent publication no. 2007/0038226; US patent publication no.2010/0137899; US patent publication no. 2010/0186748 titled“Endotracheal Tube Cleaning Apparatus”; US patent publication no.2010/023885;

U.S. Pat. No. 6,082,361; 6,318,368; 5,709,691; WO 2011/094517; US2011/180072; WO 2010/091309; US 2006/099434; US 2007/089748; US2007/024288; US 5,067,497; PCT patent publication WO 89/07466; PCTpatent publication WO 2007/146613; U.S. Pat. No. 5,125,893 titled“Suction catheter with wall lumen for irrigation”; U.S. Pat. No.6,923,184 titled “Suction system with high efficiency suction controlvalve”; U.S. Pat. No. 7,051,737 titled “Mucus Shaving Apparatus forEndotracheal Tubes”U.S. Pat. No. 7,669,600 titled “Endotracheal TubeCleaning Apparatus”; U.S. Pat. No. 4,762,125 titles “Balloon-tippedsuction catheter”; U.S. Pat. No. 4,351,328; 5,738,091; 6,602,219;6,612,304; 6,805,125; 6,935,339; 7,273,473; US patent application20090178681

Suction catheters are commonly used to aspirate trachea-bronchial fluidsin patients ventilated with endo-tracheal tube (ETT) devices. Aproblematic aspect of the use of suction catheters is the presence ofbacterial biofilm within the ETT lumen through which the suctioncatheter passes. Consequently, as the suction catheter is inserted,there is high risk of it carrying bacterial biofilm from the ETT lumendeeper into the bronchial tree where the suction catheter reaches, andthereby increasing the risk of lung infection. Moreover, buildup ofsubstantial biofilm thickness reduces the effective free lumen of theETT for air passage. Therefore, there is a need for maintaining cleanerETT lumen between suction operations, and preventing buildup ofsignificant biofilm thickness.

Another application is the use of cleaning catheters to clean the lumenof other catheters. An example of such cleaning catheter device isillustrated in FIG. 1c adapted from PCT patent publication WO 89/07466.These devices are mostly intended for the removal of substantial localclogging of the tube lumen. Yet such devices would be inefficient forcleaning of thin bio film buildup on the lumen surface of medical devicecatheters such as endo tracheal tubes.

Prior art of ETT lumen cleaning devices include U.S. Pat. No. 7,051,737titled “Mucus Shaving Apparatus for Endotracheal Tubes”, and U.S. Pat.No. 7,669,600 titled “Endotracheal Tube Cleaning Apparatus”, US patentpublication no. 2010/0186748 titled “Endotracheal Tube CleaningApparatus”, and references therein. Examples of prior art devices areprovided in FIGS. 2a -2 d.

The art of suction catheters is exemplified in U.S. Pat. No. 5,125,893titled “Suction catheter with wall lumen for irrigation”, U.S. Pat. No.6,923,184 titled “Suction system with high efficiency suction controlvalve”, and U.S. Pat. No. 4,762,125 titles “Balloon-tipped suctioncatheter”.

The type of “closed suction systems” are where the suction catheter canbe used repeatedly without being detached from the tube system includingthe ventilation air supply. Such types of systems are known in the artof suction catheters, as exemplified in the discussion of U.S. Pat. No.6,923,184 and PCT patent publication WO 2007/146613, as well as U.S.Pat. Nos. 5,738,091, 6,602,219, 6,612,304, 6,805,125, 6,935,339,7,273,473, US patent application 20090178681, and references therein(together “closed system art”). Representative prior art devices areillustrated in FIG. 1a and FIG. 1b . Such systems employ a tubingconnector with at least two ports—one for air delivery and one forcatheter delivery. U.S. Pat. No. 6,923,184 further discloses the optionfor cleaning the external surface of the catheter flexible shaft in achamber located in front of the isolator seal of the multi-port tubingconnector. The discussion of the closed system art patents is in thecontext of suction catheters.

Several problems plague present art devices: (a) The suction flexibleshaft is coming up from the ETT with significant amount of bacterialrich slime drawn up bronchi; (b) the closed suction system needs to bereplaced every about 48h due to risk of bacterial proliferation on theflexible shaft exterior surface wall; (c) the ETT lumen cleaningoperation is performed by a distinct catheter which requiresdisconnection of ventilation process and/or tube connection; (d) the ETTlumen cleaning sweeps up bio film which itself require removal from thecleaning catheter, and this removal is done in a manual open way and notwithin a closed system.

SUMMARY OF EMBODIMENTS

Some embodiments of the present invention relate to a wiping device forcleaning an inner surface of a ventilation tube in a closed ventilationsystem where air is mechanically forced into the ventilation tube by anexternal ventilator. The wiping device includes an elongate flexiblemain body, an width-expandable wiping element (e.g. an inflatableballoon), one or more suction orifice(s) and one or more fluid deliveryorifice(s).

In order to clean an inside surface of a ventilation tube, it ispossible to carry out (e.g. simultaneously or in any order) a wipingoperation, a fluid delivery operation and a suction operation. In someembodiments, during the wiping operation the width-expanded wipingelement (e.g. the inflated balloon) moves longitudinally within theventilation tube when in contact with an inner surface thereof—e.g. towipe material located on the ventilation tube inner surface (e.g.biofilm). In some embodiments, during the fluid delivery operation,stream(s) of fluid (e.g. liquid stream(s) and/or gas stream(s) and/orstream(s) of a gas/liquid mixture for example a mist stream or astream(s) of liquid including bubbles within) are sent, via the fluiddelivery orifice(s), into the ventilation tube (e.g. incident upon aninner surface of the ventilation tube). In some embodiments, during thesuction operation, material in the ‘interstitial region’ outside of themain body and within the ventilation tube is suctioned out of theventilation tube.

Examples of suctioned material that may be suctioned out of theinterstitial region include (i) derivatives of biofilm that has beenwiped away from an inner surface, (ii) derivatives of fluid deliveredinto the interstitial region, and (iii) mixtures thereof.

Examples of ventilation tubes which may be cleaned include anendo-tracheal tubes (ETT) and tracheostomy ventilation tubes.

In some embodiments, a distal end of the flexible main body (i.e. of the‘closed system device’) may be inserted into the ventilation tube viathe ventilation tube proximal end at a time that a patient is beingventilated. In some embodiments, the flexible main body distal snugglyand slidably traverses an interior region of a ventilation tubeassembly, which is mechanically coupled to a proximal end of theventilation tube to form a substantially air-tight connection.

After insertion of a distal end of the elongate flexible main body intothe ventilation tube (i.e. at a time that the main body traverses theinterior of the ventilation tube assembly), an expandable wiping element(e.g. inflatable balloon) mounted to the elongate flexible main body(e.g. at or near a distal end thereof) is then caused to width-expand(e.g. by inflation with a liquid or gas or any combination thereof). Insome embodiments, the width-expandable wiping element is expanded (e.g.by inflation) so as that a surface of the wiping element (e.g. balloonwall) is brought into contact with the ventilation tube inner surface.

As noted above, when the wiping element is in contact with the innersurface of the ventilation tube, it is possible to wipe away materiallocated on the inner surface.

In some embodiments, width expansion of the width-expandable wipingelement may be useful for creating a ‘slidable boundary’ which at leastpartially obstructs fluid communication between (i) a ‘more proximalportion of the interstitial region’ outside of the main body within theventilation tube from (ii) more distal locations within the ventilationtube—i.e. a more distal portion of the interstitial region and/orlocations in the ventilation tube that are distal of the balloonposition. As will be discussed below, by at least partially obstructingfluid communication between the proximal and distal portions of theinterstitial region (e.g. by balloon inflation) so as to ‘significantlyhinder’ (but not necessarily completely prevent) this fluidcommunication, it is possible to introduce negative pressure (i.e. viasuction orifice(s)) predominantly into the proximal portion of theinterstitial region.

In this sense, even if the wiping element (e.g. balloon) does notcompletely prevent fluid communication between the more proximal andmore distal portions of the tube interior, the expanded wiping element(e.g. inflated balloon) may hinder and/or at least partially obstructssuch communications. Thus, in some embodiments, the width-expandedwiping element (e.g. inflated balloon) is ‘boundary-forming’ so as toform a boundary between the two regions (i.e. more proximal and moredistal to the wiping element) of the interstitial region outside of themain body and within the ventilation tube. The ‘boundary-forming’ wipingelement (e.g. balloon) which may or may not form a complete seal betweenthe two regions.

Mechanical motion in a longitudinal direction (e.g. in a proximaldirection) of the ventilation-tube-inner-surface-contactingwidth-expanded wiping element (e.g. inflated balloon) may wipe biofilmfrom the ventilation tube inner surface. The fluid delivery and thesuction orifice(s) may respectively stream fluid into and suctionmaterial out of the more proximal portion of the interstitial region.

Outside of the ventilation tube and proximal to the ventilation tubeconnector assembly, a pliable and/or impermeable sleeve around at leasta portion of the main body in location proximal to the tube connectorassembly inhibits contamination (e.g. inhibits the transport of microbesfrom within the ventilation tube to an ambient environment or in theopposite direction). In some embodiments, the sleeve may be deployedaround at least 5 cm or least 10 cm of the elongate flexible main bodyin locations proximal to the tube connector assembly. In someembodiments, the sleeve may be around at least a majority or at least asubstantial majority that is at least 75%, or substantially an entiretyof that is at least 90%, or an entirety of) the portion of the flexiblemain body that is proximal to the tube connector assembly and distal toa suction port in fluid communication with a suction orifice(s) (e.g.via a suction lumen(s)).

In some embodiments, the fluid delivery operation includes streamingfluid (e.g. including some sort of cleaning fluid such as water orsaline solution or disinfectant solutions or mists thereof. The term‘fluid’ broadly includes any combination of liquid and/or gas—in someembodiments, the fluid preferably includes at least some liquid forwetting) into the ‘more proximal portion’ of the interstitial region(e.g. so that fluid is incident upon the inner surface of theventilation tube—for example, to wet the interior surface of theventilation tube) via the fluid delivery port(s)—for example, locatednear the distal end of the main body and proximal to the inflatableballoon inflated in contact with the inner surface of the ventilationtube. A ‘strength’ or intensity or velocity of delivered fluid maydepend on the degree to which the fluid is pressurized before deliveryand/or on the size of the aperture through which the fluid is deliveredand/or on other factors. In some embodiments, a jet of fluid (e.g.liquid and/or a liquid-gas mixture such as a mist or liquid containingbubbles) is incident upon an inner surface of the ventilation tube.

The delivered or streamed fluid may have sufficient linear momentum tobe incident upon an inner surface of the ventilation tube. Materialproximal to the balloon within the ventilation tube (e.g. includingmaterials that was formerly biofilm and/or dirt and/or the deliveredfluid) may, after being suctioned through the suction orifice, beproximally transported out of the ventilation tube within suctionlumen(s) using negative pressure from the suction source.

A number of additional features are described herein.

According to a first example, the ballooned catheter device includes atleast two balloons mounted and/or attached to the flexible main body(e.g. at or near the distal end of flexible main body): (i) theaforementioned inflatable ‘wiping’ and/or ‘boundary forming’ balloonwhich is inflated into contact with an inner surface of the ventilationtube (i.e. inflated by a liquid or gas) and/or is inflated to‘concentrate’ suction into the proximal portion of the interstitialregion; and (ii) a second balloon (referred to as the ‘more proximalballoon’) which may or may not be inflatable, is located proximal to theinflatable ‘boundary-forming’ or ‘wiping’ balloon, and which includesone or more of the fluid delivery ports.

In some embodiments, the inflatable ‘boundary-forming’ balloon iscompletely fluid-tight and substantially does not leak.

Alternatively, in a second example, the inflatable ‘boundary-forming’balloon is not completely fluid-tight. According to this ‘second’example, the balloon is inflated into contact with an inner surface 201of ventilation tube 60 by liquid so to maintain balloon shape to contactthe ventilation tube (i.e. for wiping) and/or so as to at leastpartially obstruct fluid communication within the tube. However, for theexample where the ‘boundary-forming balloon’ is not fluid tight, some ofthe liquid within the balloon leaks into the ‘more proximal portion’ ofthe interstitial liquid via one or more relatively small holes in thesurface of the inflatable ‘boundary-forming’ balloon. Although thesehole(s) are small enough so as to allow the ‘boundary-forming’ balloonto maintain its shape and slidable contact with the ventilation tubeinner surface (i.e. when receiving a relatively steady supply ofpressurized liquid via the lumen(s)), the holes are large enough toallow liquid within the ‘boundary-forming’ inflatable balloon to streaminto the more proximal section of the interstitial region—for example,so that a stream of fluid is incident upon the ventilation tube innersurface.

In this second example, the hole(s) function as the aforementioned‘fluid delivery ports’ discussed herein. As will be discussed below,this embodiment may provide a number of safety features discussed below.

In some embodiments, the one or more ‘fluid delivery ports’ include aplurality of fluid delivery ports, and a ‘multiple direction’ feature isprovided whereby fluid (e.g. liquid and/or gas and/or a liquid-gasmixture such as a mist or a bubble-containing-liquid) is simultaneouslystreamed into the ‘more proximal’ portion of the interstitial region inmultiple directions. Towards this end, the catheter device may include(i) a first fluid delivery port disposed at a first location on a firstside of the flexible main body; and (ii) a second fluid delivery portdisposed at a second location substantially (e.g. within a tolerance of75 degrees or more) on a second side of the flexible main body. Notwishing to be bound by any theory, it is noted that the streaming offluid in substantially opposite directions may facilitate the cleaningof the ventilation tube inner surface.

A number of implementations of this ‘multi-direction’ feature aredescribed herein. In a first implementation, the ‘more proximal balloon’may include fluid delivery ports that face in different directionsrelative to an elongate or ‘central’ axis of the flexible main body. Ina second implementation, the liquid-filled boundary-forming balloon thatincludes multiple ‘small’ holes. For example, it is possible to providefirst and second holes that both face in a proximal direction but whichface in substantially the opposite direction relative to the flexiblemain body central axis.

In a third implementation, the device includes a plurality of fluiddelivery ports located substantially on a surface of the flexible mainbody. In some embodiments, a first of the fluid delivery ports faces ina first direction while a second of fluid delivery ports facessubstantially in the opposite directions.

Some embodiments of the present invention relate to a multi-modetechnique for operating the aforementioned ballooned catheter device ina closed system. In both modes of operation, the flexible main body isinserted into the ventilation tube via the proximal end of theventilation tube and via an inner channel of a ventilation tubeconnector assembly that is sealingly connected to a proximal end of theventilator tube.

In the first operating mode, a balloon-inner wall contact within theinterstitial region is maintained by the inflatable balloon (e.g. so asto obstruct—i.e. significantly hinder—longitudinal flow betweenlocations proximal and distal to the balloon), and the suction and fluiddelivery orifice(s) are operated as described above. The suction andfluid delivery orifice(s) are operated as described in one or more ofthe previous paragraphs so as to deliver fluid (e.g. a stream of liquidor a stream of a mist) into the ‘more proximal portion’ of theinterstitial region while the slidable ‘boundary’ is maintained. Awiping operation caused by sliding the inflated balloon (i.e. inflatedinto contact with the ventilation tube inner surface) may be carried outsimultaneous with or not simultaneous with the suction and fluiddelivery operations.

In the second operating mode, the ‘boundary-forming’ balloon is deflatedand/or not sufficiently inflated to contact the ventilation tube innersurface and/or not sufficiently inflated to at least partially obstruct(i.e. and ‘significantly inhibit’) fluid communication interstitialregion into ‘more proximal’ and ‘more distal’ regions.

In the second mode of operation, suction provided by the suctioningport(s) may be used primarily to remove material from locations distalof the balloon (e.g. in the ‘more distal’ portion of the interstitialregion or even from locations that are distal to the distal end of theETT) and to transport this ‘distally-located’ material in a proximaldirection out of the ETT. One example of such ‘distally-located’material is tracheo-bronchial fluid or mucus located in the subject'strachea.

Some embodiments relate to a method of cleaning a main lumen of an ETTor tracheostomy ventilation tube 60 comprising: at a time when: (i) aventilation tube connector assembly 158 mediates a substantiallyair-tight connection between a ventilator machine and an interior of amain lumen of the ventilation tube 60 (e.g. such that air is forced fromthe ventilator machine through the ventilation tube connector assembly158 into the main lumen of the ventilation tube 60); and/or (ii) anelongate, narrow, flexible, main body 210 (e.g. of a length that is atleast 15 cm) slidably and internally traverses the ventilation tubeconnector assembly 158 without substantially breaking the substantiallyair-tight breathing circuit such that: A. a proximal end 204 of the mainbody 210 is located outside of the ventilation tube 60 proximal to theventilation tube connector assembly 158; and B. a boundary-formingballoon 588 mounted to the elongate, flexible main body 210 is locatedwithin the ventilation tube 60, and/or (iii) at least a portion of themain body is a connection-assembly-proximal-portion 598 that is locatedproximal to the ventilation tube connector assembly 158; and/or (iv) atleast 5 cm of the connection-assembly-proximal-portion 598 is coveredand/or enveloped by a substantially impermeable pliable sleeve; carryingout the following steps: A. effecting a balloon-inflation operation byforcing a fluid from outside of the ventilation tube 60 into theboundary-forming balloon 588 so that inflation of the boundary-formingballoon 588 obstructs (i.e. significantly hinders) fluid flow to forms aslidable boundary 770 between: I. a more proximal portion 774 of aninterstitial region outside of the flexible main body and within theventilation tube; and II. locations 778 within the ventilation tube 60that are distal to slidable boundary 770, the slidable boundary 770being located in a distal half of the ventilation tube 60; A. concurrentwith a maintaining of the slidable boundary 770, effecting a fluiddelivery operation by forcing a pressurized fluid from outside of theventilation tube 60 into the more proximal portion 774 of theinterstitial region through one or more fluid delivery orifice(s) 525that is: I. mechanically coupled to the flexible main body 210; II.located proximal of the slidable boundary 770 and longitudinally closerto the slidable boundary 770 location than to a proximal opening of theventilation tube; C. concurrent with the maintaining of the slidableboundary 770, proximally suctioning, out of the ventilation tube 60,material located: I. within the more proximal portion 774 of theventilation tube 60; II. in the distal half of the ventilation tube, viaone or more suction orifice(s) 440 that is: I. mechanically coupled tothe flexible main body 210; and II. located proximal of the slidableboundary and longitudinally closer to the slidable boundary 770 locationthan to a proximal opening of the ventilation tube.

In some embodiments, the one or more suction orifice(s) is(are)longitudinally displaced from the slidable boundary 770 and/or to amidpoint of the boundary-forming balloon 588 by at most asuction-orifice-displacement-value that is at most 3 cm.

In some embodiments, i. the pressurized fluid (e.g. pressurized liquidor a pressurized mist or a pressurized bubble-containing liquid) issimultaneously forced through first 525A and second 525B fluid deliveryorifices to respectively produce first 556A and second 556B fluidstreams that are respectively and simultaneously incident upon an innersurface 201 of the ventilation tube 60 at first 552A and second 552Blocations; and ii. the first 552A and second 552B locations aresubstantially on opposite sides of the ventilation tube 60 inner surface201 within a tolerance that is at most 75 degrees.

In some embodiments, each fluid-delivery-orifice is proximally displacedfrom the slidable boundary 770 and/or from a midpoint of theboundary-forming balloon 588 by at most afluid-orifice-displacement-value that is at most 3 cm, or at most 2 cm.

In some embodiments, the fluid-orifice-displacement-value that is atmost 2 cm.

In some embodiments, the tolerance is at most 45 degrees or at most 25degrees.

In some embodiments, the first 525A and second 525B fluid deliveryorifices are respectively supplied via first 520A and second 520Bfluid-delivery lumens.

In some embodiments, the first 520A and second 520B second fluiddelivery lumens are simultaneously supplied by a common pressurizedfluid chamber (e.g. containing pressurized liquid or another pressurizedfluid such as a pressurized mist or bubbled liquid).

In some embodiments, immediately before exiting each fluid deliveryorifice, the delivered fluid is pressurized to at least 1.5 atmospheresor at least 2 atmospheres or at least 3 atmospheres.

In some embodiments, each fluid delivery orifice 525 has a width of atmost 3 mm or at most 2 mm or at most 1 mm, or at most 0.5 mm, at most0.3 mm, at most 0.2 mm.

In some embodiments, each fluid delivery orifice 525 has width that isat most 50% of an average width of the 440 suction orifice(s).

In some embodiments, each fluid delivery orifice 525 has width that isat most 25% of an average width of the 440 suction orifice(s).

In some embodiments, each fluid delivery orifice 525 has width that isat most 10%, or at most 5%, of an average width of the 440 suctionorifice(s).

In some embodiments, at a time that the slidable boundary is maintained,substantially no suction or suction at a significantly lower proximalair flow rate than the suction of step C is applied to locations distalof the slidable boundary.

In some embodiments, the suction-orifice-displacement-value is at most 2cm or at most 1 cm or at most 0.5 cm.

In some embodiments, the ventilation tube 60 is an ETT. In someembodiments, the ventilation tube 60 is a tracheostomy tube.

In some embodiments, the fluid delivery operation and the suctioning arecarried out simultaneously.

In some embodiments, the fluid delivery operation and the suctioning arecarried out sequentially.

In some embodiments, the method further comprises: concurrent to themaintaining of the slidable boundary, longitudinally moving theboundary-forming balloon 588 so as to mechanically dislodge and/orloosen biofilm material located on the inner surface 201 of theventilation tube 60.

In some embodiments, the longitudinal moving is carried outsimultaneously with the fluid delivery operation and/or the suctioning.

In some embodiments, at least one of the fluid delivery orifice(s) 525are deployed to and/or voids within a second balloon 586 deployed distalto the boundary-forming balloon 588.

In some embodiments, the second balloon 586 is inflatable.

In some embodiments, the second balloon 586 is not inflatable.

In some embodiments, at least one of the at least one of the fluiddelivery orifice(s) 525 is an inner-surface-facing void in the main body210 facing towards the inner surface 201 of the ventilation tube 60 or ainner-surface-facing-void in a fluid-delivery lumen 520 that at leastspans a longitudinal range between the fluid delivery orifice(s) 525 anda location on or within the main body 210 that is proximal to theventilation tube connector assembly 158.

In some embodiments,

i. at least one of the at least one of the fluid delivery orifice(s) 525is a void in the boundary-forming balloon 588 so that theboundary-forming balloon 588 is leaky;

ii. forcing of pressurized liquid into the boundary-forming balloon 588is operative to carry out at least some of both of the balloon-inflationoperation and the fluid-delivery of the fluid-delivery operation.

In some embodiments, a surface of the boundary-forming balloon 588 is atleast 90% or at least 95% and/or at most 99% by surface area,substantially impermeable.

In some embodiments, the boundary-forming 588 balloon is substantiallysealed and is not leaky.

In some embodiments, the method further comprises carrying out theadditional step of: D. concurrent with the maintaining of theventilation circuit, and at a time that the boundary-forming balloon 588mounted to the elongate, flexible main body 210 is located within theventilation tube 60 and in a non-obstructing or so that the slidableboundary (i.e. for significantly hindering fluid flow within theventilation tube 60) with the inner surface 201 of the ventilation tube60 is not maintained and/or non-contact mode so that balloon 588 is notinflated into contact with the inner surface 201 of ventilation tube 60,proximally suctioning into the suction orifice(s) 440 material that islocated: I. within the ventilation tube 60 and distal to theboundary-forming balloon 588; and/or II. distal to the ventilation tubedistal end 60 so that the material located distal to the ventilationtube distal end 60 enters an interior region of ventilation tube 60 enroute to the suction orifice(s), wherein the suctioning step when theboundary-forming balloon 588 is in non-obstructing and/or non-contactmode is carried out to proximally transport material suctioned in step Dproximally out of ventilation tube 60 via a proximal opening of theventilation tube 60.

Some embodiments relate to a system ballooned cleaning systemcomprising: a. an ETT or tracheostomy ventilation tube 60; b. aventilator machine; c. ventilation tube connector assembly 158 directlyor indirectly connected to both the ventilation tube 60 and the aventilator machine so as to mediate a substantially air-tight connectionbetween the ventilator machine and an interior of the ventilation tube;d. an elongate, narrow, flexible, main body 210 of a length that is atleast 15 cm (or at least 20 cm or at least 25 cm or at least 30 cm); e.a boundary-forming balloon 588 mounted to the elongate, flexible mainbody 210, the main body configured to slidably and internally traversethe ventilation tube connector assembly 158 without substantiallybreaking the air-tight connection between the ventilator machine and aninterior of the ventilation tube such that: I. a proximal end 204 of themain body 210 is located outside of the ventilation tube 60 proximal tothe ventilation tube connector assembly 158; and II. the mountedboundary-forming balloon 588 is located in the ventilation tube 60; theboundary-forming balloon 588 being configured so that, when the mountedboundary-forming balloon 588 is located in the ventilation tube 60,inflation of the boundary-forming balloon 588 forms a slidable boundarybetween: I. a more proximal portion 774 of an interstitial regionoutside of the flexible main body and within the ventilation tube; andII, locations 778 within the ventilation tube 60 that are distal toslidable boundary, f. a plurality of fluid-communication lumens locatedwithin and/or along the elongate, flexible main body 210 including oneor more suction lumen(s) 530 and one or more fluid delivery lumen(s)520; g. one or more fluid delivery orifice(s) 525 that: I. is(are)mechanically coupled to flexible main body 210 so that longitudinalmotion of the flexible main body 210 induces longitudinal motion of thefluid delivery orifice(s) (e.g. so the orifice(s) move closer towards a;II. is located proximal to the slidable boundary when theboundary-forming balloon 558 is inflated into contact with an innersurface of tube 60 to form a slidable ‘boundary’; h. one or more suctionorifice(s) 440 that: I. is(are) mechanically coupled to flexible mainbody 210 so that longitudinal motion of the flexible main body 210induces longitudinal motion of the fluid delivery orifice(s);

II. is located proximal to the slidable boundary when the boundaryforming balloon 558 is inflated to form the slidable boundary; i. asource of pressurized fluid (e.g. located outside of the ventilationtube 60) and operative, at least some of the time and concurrent withthe maintaining of the slidable boundary, to deliver pressurized fluidinto more proximal portion 774 of the interstitial region such that thepressurized fluid travels to the fluid delivery orifice(s) 525 via thefluid delivery lumen(s) 520 and enters into the more proximal portion774 of the interstitial region via the fluid delivery orifice(s) 525;and j. a suction source 603 located outside of the ventilation tube 60,and operative, at least some of the time and concurrent with themaintaining of the slidable boundary, to proximally transport materiallocated within the more proximal portion 774 of the interstitial regionout of the ventilation tube 60 such that the transported material exitsthe more proximal portion 774 of the interstitial region via the suctionorifice(s) 440, enters into suction lumen(s) 530 and proximally exitsthe ventilation tube within suction lumen(s) 530.

In some embodiments, boundary-forming balloon 588 is mounted to the mainbody 210 at a location in a distal half (or third or quarter or fifth ortenth) of the main body 210.

In some embodiments, the fluid source (e.g. 602 and/or other examples)and the suction source 603 are respectively operative, in combinationwith the lumens and the orifices, to effect the fluid delivery and thesuctioning when the boundary-forming balloon 588 is located in a distalhalf of the ventilation tube 60.

Some embodiments closed-system ballooned cleaning system for use with anETT or tracheostomy ventilation tube 60, a ventilator machine, a sourceof pressurized fluid and a source of suctioning 603, the cleaning systemcomprising: a. a ventilation tube connector assembly 158 operative, whendirectly or indirectly connected to both the ventilation tube 60 and theventilator machine, to mediate a substantially air-tight mediatingconnection between the ventilator machine and an interior of theventilation tube via an interior of the ventilation tube connectorassembly 158; b. an elongate, narrow, flexible, main body 210 of alength that is at least 15 cm (or at least 20 cm or at least 25 cm or atleast 30 cm); c. a boundary-forming balloon 588 mounted to the elongate,flexible main body 210, the flexible main body operative to slidably andinternally traverse the ventilation tube connector assembly 158 withoutsubstantially breaking the air-tight connection between the ventilatormachine and an interior of the ventilation tube such that: I. a proximalend 204 of the main body 210 is located outside of the ventilation tube60 proximal to the ventilation tube connector assembly 158; and II. themounted boundary-forming balloon 588 is located in the ventilation tube60; the boundary-forming balloon 588 being configured so that, when themounted boundary-forming balloon 588 is located in the ventilation tube60, inflation of the boundary-forming balloon 588 forms a slidableboundary between: I. a more proximal portion 774 of an interstitialregion outside of the flexible main body and within the ventilationtube; and II. locations 778 within the ventilation tube 60 that aredistal to slidable boundary, f. a plurality of fluid-communicationlumens located within and/or along the elongate, flexible main body 210including one or more suction lumen(s) 530 and one or more fluiddelivery lumen(s) 520; g. one or more distal fluid delivery orifice(s)525 that: I. is(are) mechanically coupled to flexible main body 210 sothat longitudinal motion of the flexible main body 210 induceslongitudinal motion of the fluid delivery orifice(s); II. is locatedproximal to the slidable boundary when the boundary-forming balloon 558is inflated to form the slidable boundary; h. one or more distal suctionorifice(s) 440 that: I. is(are) mechanically coupled to flexible mainbody 210 so that longitudinal motion of the flexible main body 210induces longitudinal motion of the fluid delivery orifice(s); IL islocated proximal to the slidable boundary when the boundary formingballoon 558 is inflated to form the slidable boundary;

i. a rigid or resilient proximal fluid delivery port 827 in fluidcommunication with proximal interior location 829 within fluid deliverylumen(s) 520 that is proximal to the connector assembly 158, theproximal fluid delivery port 827 being configured, when directly orindirectly connected to the source of pressurized fluid (e.g. 602 orother example(s)), to mediate a substantially fluid-tight (e.g.liquid-tight) coupling between the source of pressurized fluid and thefluid delivery lumen proximal interior location 829 via an interior ofthe proximal fluid delivery port 827, the proximal fluid delivery port827, the fluid delivery lumen(s) 520 and the fluid delivery orifice(s)525 being operative so that pressurized fluid distally delivered fromthe source of pressurized fluid into the fluid delivery lumen(s) 520 viathe proximal fluid delivery port 827 distally flows through the fluiddelivery lumen(s) 520 to fluid delivery orifice(s) 525 and enters intothe more proximal portion 774 of the interstitial region via the fluiddelivery orifice(s) 525; and j. a proximal rigid or resilient suctionport 830 in fluid (e.g. liquid) communication with proximal interiorlocation 531 within suction lumen(s) 530 that is proximal to theconnector assembly 158, the proximal suction port 830 being configured,when directly or indirectly connected to the suction source 603, tomediate a substantially air-tight coupling between the suction source603 and the suction lumen proximal interior location. 531 via aninterior of the proximal suction port 830, the proximal suction port830, the suction lumen(s) 530 and the suction orifice(s) 440 beingoperative so that negative pressure applied via the proximal suctionport 830 causes material to exit the more proximal portion 774 of theinterstitial region via the suction orifice(s) 440 and travel proximallyto the suction lumen proximal interior location 531.

Some embodiments relate to a ballooned cleaning apparatus comprising: a.an elongate, narrow, flexible, main body 210 having length of at least15 cm (or at least 20 cm or at least 25 cm or at least 30 cm); and awidth of between 1 mm and 1 cm (for example, at least 3 mm and/or atmost 6 mm—for example, between 3 and 6 mm); b. a boundary-formingballoon 588 mounted to the main body 210 in a distal half of the mainbody 210, the boundary-forming balloon 588 being inflatable so that whenthe balloon 588 is inserted into an enclosing tube having a diameterbetween 4 and 11 mm so that the balloon 588, inflation of the balloon588 causes the balloon outer surface to contact an inner surface of theenclosing tube forms a slidable boundary between: I. a more proximalportion 774 of an interstitial region outside of the flexible main bodyand within the enclosing tube; and locations 778 within the ventilationtube 60 that are distal to the enclosing tube, c. a plurality of lumenslocated within and/or along the main body 210 including one or moresuction lumen(s) 530 and one or more fluid delivery lumen(s) 520, eachlumen of the plurality of lumens substantially spanning a length of themain body 210 between the proximal end 204 of main body 210 andboundary-forming balloon 588, each fluid delivery lumen(s) having aninner width of at most 3 mm (for example, at most 2 mm or at most 1 mmand/or at least 0.1 mm or at least 0.2 mm or at least 0.5 mm) eachsuction lumen(s) having an inner width of between 1 and 5 mm (forexample, at least 2 mm and/or at least 5 mm) (for example, a ratiobetween an inner width of the suction lumen and an inner width of thefluid delivery lumen).at least one of the plurality of lumens in fluidcommunication with the inner surface of the balloon; d. one or moredistal suction orifice(s) 440 that: i. have an inner width of between 1and 5 mm; is(are) mechanically coupled to flexible main body 210 so thatlongitudinal motion of the flexible main body 210 induces longitudinalmotion of the fluid delivery orifice(s); iii. is located proximal to theslidable boundary when the boundary-forming balloon 558 is inflated toform the slidable boundary longitudinally displaced from the slidableboundary by at most 2 cm; e. one or more distal fluid deliveryorifice(s) 525 that: i. have an inner width of at most 3 mm and at most30% of the inner width of the distal suction orifice(s) 440; ii. is(are)mechanically coupled to flexible main body 210 so that longitudinalmotion of the flexible main body 210 induces longitudinal motion of thefluid delivery orifice(s) 525; iii. is located proximal to the slidableboundary when the boundary-forming balloon 558 is inflated to form theslidable boundary and is longitudinally displaced from the slidableboundary by at most 2 cm.

In some embodiments, the flexible main body 210 includes aconnection-assembly-proximal portion 598, at least 5 cm of which iscovered and/or enveloped by a substantially impermeable pliable sleeve610.

In some embodiments, a distal end of sleeve 610 is directly orindirectly attached to ventilation tube connector assembly 158—forexample, so that the main body 210 may slide through the sleeve. Incontrast, in some embodiments, a proximal end of sleeve 610 isconfigured to have a substantially fixed longitudinal position relativeto a proximal end of elongate flexible main body 210.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 describe prior-art devices.

FIGS. 4-25 illustrate systems, apparatus and portions thereof forcleaning an inner surface of a ventilation tube and/or hinderingaccumulation of biofilm thereon according to some embodiments.

FIGS. 26-29 are flowcharts of methods for cleaning an inner surface of aventilation tube according to some embodiments.

BRIEF DESCRIPTION OF EMBODIMENTS

The invention is herein described, by way of example only, withreference to the accompanying drawings. With specific reference now tothe drawings in detail, it is stressed that the particulars shown are byway of example and for purposes of illustrative discussion of thepreferred embodiments of the exemplary system only and are presented inthe cause of providing what is believed to be a useful and readilyunderstood description of the principles and conceptual aspects of theinvention. In this regard, no attempt is made to show structural detailsof the invention in more detail than is necessary for a fundamentalunderstanding of the invention, the description taken with the drawingsmaking apparent to those skilled in the art how several forms of theinvention may be embodied in practice and how to make and use theembodiments.

For brevity, some explicit combinations of various features are notexplicitly illustrated in the figures and/or described. It is nowdisclosed that any combination of the method or device featuresdisclosed herein can be combined in any manner—including any combinationof features—any combination of features can be included in anyembodiment and/or omitted from any embodiments.

Definitions

For convenience, in the context of the description herein, various termsare presented here. To the extent that definitions are provided,explicitly or implicitly, here or elsewhere in this application, suchdefinitions are understood to be consistent with the usage of thedefined terms by those of skill in the pertinent art(s). Furthermore,such definitions are to be construed in the broadest possible senseconsistent with such usage.

Some embodiments relate to a ‘width’ of an objection—for example, a‘width’ of an elongate flexible main body 210 or a width of anorifice(s) or a width of a lumen. A ‘width’ is defined as the squareroot of the cross section.

A ‘fluid’ (e.g. a cleaning fluid) may refer to flowable liquid orliquid-gas mixture such as: (i) a liquid; (ii) a mist (e.g. droplets ofliquid suspended within a gas such as air) or (iii) any other mixture ofliquid and gas (for example, having a significant liquid content—e.g. amist or bubbled liquid including gas bubbles). Some embodiments refer todelivering of a ‘cleaning liquid’ or a ‘source of pressurizedliquid’—this is only one example. Any reference to a liquid (e.g.pressurized liquid, a liquid stream, a liquid lumen, a fluid deliveryorifice, or other reference or combination thereof) may either refer toan actual liquid or to a gas-liquid mixture (e.g. a mist or any othergas-liquid mixture). ‘Fluid communication’ or ‘liquid communication’refers to the ability of a liquid or a gas-liquid mixture to flowbetween two locations, and are used interchangeably. Throughout thepresent disclosure, a ‘source of liquid’ (e.g. pressurized liquid) and a‘source of fluid’ (e.g. liquid or a liquid-gas mixture such as a mist)may be used interchangeably.

‘Negative pressure’ is suction—‘negative pressure’ and ‘suction’ areused interchangeably in the present disclosure.

A ‘wiping element’ is a ‘wiper’ and is used to wipe away materiallocated on an inner surface 201 of ventilation tube 60. Examples ofwiping elements include but are not limited to inflatable balloons,stents, and any other width-expandable object configured to wipe awaymaterial on the inner surface 201 of ventilation tube 60.

Some embodiments of the present invention relate to a wiping device forcleaning an inner surface of a ventilation tube in a closed ventilationsystem where an oxygen-including gas (e.g. air) is mechanically forcedinto the ventilation tube by an external ventilator. The wiping deviceincludes an elongate flexible main body, an width-expandable wipingelement (e.g. an inflatable balloon), one or more suction orifice(s) andone or more fluid delivery orifice(s).

In order to clean an inside surface of a ventilation tube, it ispossible to carry out (e.g. simultaneously or in any order) a wipingoperation, a fluid delivery operation and a suction operation. In someembodiments, during the wiping operation the width-expanded wipingelement (e.g. the inflated balloon) moves longitudinally within theventilation tube when in contact with an inner surface thereof—e.g. towipe material located on the ventilation tube inner surface (e.g.biofilm). In some embodiments, during the fluid delivery operation,stream(s) of fluid (e.g. liquid stream(s) and/or gas stream(s) and/orstream(s) of a gas/liquid mixture for example a mist stream or astream(s) of liquid including bubbles within) are sent, via the fluiddelivery orifice(s), into the ventilation tube (e.g. incident upon aninner surface of the ventilation tube). In some embodiments, during thesuction operation, material in the ‘interstitial region’ outside of themain body and within the ventilation tube is suctioned out of theventilation tube.

FIGS. 4-6 and 8-22 relate to ‘balloon embodiments’ where the wipingelement is an inflatable balloon 588. FIG. 23A-23B illustrate anon-balloon embodiment where the width-expanding wiping element is otherthan a balloon. Unless specified otherwise, it is possible to substitutean inflatable balloon with any other width-expandable wiping element.

FIG. 4A illustrates a closed system cleaning system comprising: (i) anETT or tracheostomy ventilation tube 60; (ii) a ventilator machine 900;(iii) a ventilation tube connector assembly 158 including a ventilatorport 664, a ventilation tube port 660, and a main body inlet 640; and(iv) a flexible, elongate main body 210 having proximal 204 and distal208 ends.

In some embodiments, the cleaning system is operative to clean aninterior 201 of the ventilation tube 60 at a time when ventilation tubeconnector assembly 158 is directly or indirectly connected to both theventilation tube 60 and the ventilator machine 900 so as to mediate asubstantially air-tight connection (e.g. via an interior chamber(s)and/or conduit(s) of ventilation tube connector assembly 158) thebetween the ventilator machine and an interior of the ventilation tube.In one non-limiting example, an interior region and/or outer shape ofventilation tube port 660 matches a proximal end 62 of the ventilationtube 60 to create a substantial air-tight seal. In one non-limitingexample, a tube or other conduit of a tube assembly (NOT SHOWN) may beconnected to ventilator port 664 so that an interior of ventilator port664 receives air from the ventilator machine and is in fluidcommunication with the ventilator machine 900 in a substantiallyair-tight manner.

In some embodiments, flexible, elongate main body 210 slidably andsnugly passes through an interior of ventilation tube connector assembly158 so that a proximal-distal direction of the main body 210 is alignedwith a proximal-distal direction of the ventilation tube connectorassembly 158—i.e. distal end 208 of flexible main body 208 is on adistal side 908 of ventilation tube connector assembly 158 and proximalend 208 of flexible main body 208 is on a proximal side 908 ofventilation tube connector assembly 158.

It is appreciated that when elongate main body 210 “snugly” passesthrough an interior of ventilation tube connector assembly 158 thatthere is no requirement for the fit between an outer surface of mainbody 210 and an interior of connector assembly 158 to be ‘snug’ in everylocation within connector assembly 158. In some embodiments, a ‘snugfit’ in one or more locations is sufficient to provide the ‘snuglypassing through’ feature.

In some embodiments, flexible, elongate main body 210 slidably andsnugly passes through the interior of ventilation tube connectorassembly 158 in a manner that does not substantially break thesubstantially air-tight connection between the ventilator machine 900and the interior of the ventilation tube 60.

The systems 600A-C of FIGS. 4-16 all include an inflatable‘boundary-forming balloon’ 588, mounted to the flexible main body 200.When inflated, the boundary forming balloon, in some embodiments, mayprovide two types of functionality: (i) an ‘flow obstructionfunctionality’ to significantly hinder fluid flow between locations onopposite longitudinal sides of the boundary-forming balloon (asdiscussed below, this may be useful for ‘concentrating’ suction so thatthe suction is predominantly in a proximal portion 774); and (ii) awiping functionality useful for cleaning the inner surface 201 ofventilator tube 60.

One salient feature of the ballooned cleaning apparatus provided by someembodiments is that the cleaning apparatus operates in a ‘closed system’environment. During operation, it is possible to clean the inner surface201 of ventilator tube 60 when the ventilation tube connector assembly158-mediated substantially air-tight seal between (i) ventilator machine900 and/or an interior of ventilator port 664 and (ii) an interior ofventilation tube 60 and/or an interior of ventilation tube port 660 ismaintained—this substantially air-tight seal is referred to as the‘ventilation machine-ventilator tube’ seal.

As will be discussed below, concurrent with a maintaining of this‘ventilation machine-ventilator tube’ seal, it is possible to positionthe mounted balloon 588 within the ventilation tube 60 (e.g. in a distalhalf of ventilation tube 60) for example, by moving a distal end 208 ofthe main body 210 in a distal direction towards a distal end 64 ofventilation tube 60. For example, it is possible to distally move themounted balloon 588 at a time when the mounted balloon 588 is in a‘non-contact state’ (i.e. not in contact with an inner surface 201 ofventilation tube 60). After the boundary-forming balloon 588 is thuspositioned, inflation of the balloon induces contact between an outersurface of the balloon 588 and an inner surface 201 of ventilation tube60 and/or ‘obstructs’ (i.e. significant hinders) longitudinal flowbetween proximal 774 and distal 778 portions of the interior ofventilation tube 60. As will be disused below, this slidable ‘boundary;between proximal 774 and distal 778 portions is useful for facilitatingthe cleaning of the inner surface 201—for example, for substantiallyconfining locations of negative pressure and/or fluid (e.g. pressurizedfluid such as pressurized liquid or pressurized fluid) introduced intoan interstitial region outside of main body 210 and within ventilationtube 60 so that the suction or pressurized fluid is introduced‘predominantly’ in a proximal portion 774.

In some embodiments, as illustrated in various figures (e.g. FIGS. 4A,8, 14), inflatable “boundary forming” or‘inflated-into-contact-with-an-inner-surface-of-ventilation-tube’balloon 588 is mounted to flexible main body 210 at a location that isor near a distal end 208 or flexible main body 210.

In different embodiments, a location ‘near a distal end’ 208 of mainbody 210 may refer to: (i) in a distal half of flexible main body 210;or (ii) in a distal third of flexible main body 210, or (iii) in adistal fifth of flexible main body 210, or in (iv) a distal tenth offlexible main body 210.

Also shown in FIG. 4A is a second balloon 550 (which may or may not beinflatable) which is mounted to flexible main body 210 at a ‘secondballoon mounting location’ that is proximal to a ‘boundary-formingballoon mounting location’ of the main body 210 to which “boundaryforming” and/or ‘inner surface-contacting’ balloon 588 is mounted. Insome embodiments, the ‘second balloon mounting location’ is ‘near adistal end’ 208 of main body 210—for example, in a distal half or thirdor fifth or tenth of flexible main body.

In the non-limiting example of FIG. 4A, second balloon 550 includes oneor more fluid delivery orifice(s) 525 located on the surface of thesecond balloon 550. In other embodiments, the fluid delivery orifice(s)525 may be located in other locations.(e.g. see FIG. 8 or 14). Invarious embodiments, fluid (e.g. liquid or mist or any gas/liquidmixture) delivered from source of pressurized liquid 602 into aninterior of the ventilation tube 60 via fluid delivery orifice(s) 525may be used to clean an inner surface 201 of ventilation tube 60. In thenon-limiting example of FIG. 4A, fluid delivery orifice(s) 525 locatedon the surface of the second balloon 550—for example, as voids or holesin the surface of the second balloon 550. This is not a limitation, andin the examples of FIGS. 8 and 16 alternative configurations areillustrated.

Also illustrated in FIG. 4A are suction orifice(s) 440, which, in someembodiments, are supplied with negative pressure by suction source 601and facilitate cleaning of the inner surface 201 of ventilation tube 60.In some embodiments, material within the interior of ventilation tube 60may be suctioned into suction orifice(s) 440 and proximally transportedout of ventilation tube 60—e.g. to a location that is proximal ofventilation tube connector assembly 158.

As will be discussed below, fluid communication between the suctionsource 601 and/or pressurized fluid source 602 and the suction 440 orfluid delivery 525 orifice(s) may be provided by one or more connectinglumen(s) within or along the main body 210/As illustrated in FIGS.4A-4B, at least a portion 598 of elongate main body 210 is locatedproximal to ventilation tube connector assembly 158. The magnitude ofthis ‘portion’ may depend on an extent to which distal end 208 and/orballoon 588 is deployed within ventilation tube 60 and/or an extent towhich distal end 208 and/or balloon 588 is longitudinally displaced fromventilation tube connector assembly 158—for example, an extent to whichthe main body 210 slides through ventilation tube connector assembly 158in a distal direction.

Because The system or method of FIGS. 4A-4B is a ‘closed system,’ insome embodiments, the system may include a substantially impermeableand/or pliable sleeve 610 for protecting an outer surface of main body210. In some embodiments, sleeve 610 envelops and/or protects at leastsome (e.g. at least a majority or at least a substantial majority of atleast 75% or substantially all of (i.e. at least 90%)) of an outersurface of the ventilation-tube-connector-assembly-proximal portion 598of elongate main body 210. In some embodiments, sleeve 610 may providethis enveloping and/or protection functionality when a length of theventilation-tube-connector-assembly-proximal portion 598 of main body210 is at least 3 cm or at least 5 cm or at least 7 cm or at least 10cm. As noted above, in some embodiments, a length of this proximalportion 598 may be modified by sliding, in a proximal or distal end,main body 210 through ventilation tube connector assembly 158.

In some embodiments, a distal end 908 of sleeve 610 is (i) directly orindirectly attached to and/or (ii) has a location that is fixed and/orlongitudinally fixed relative to ventilation tube connector assembly158. In some embodiments, a longitudinal position of a location of adistal end 908 of sleeve 610 corresponds to a location on ventilationtube connector assembly 158 (e.g. at or near main body inlet 640) and/oris longitudinally displaced from a proximal end (e.g. corresponding tomain body inlet 640) of ventilation tube connector assembly 158 by atmost 5 cm or at most 3 cm or at most 2 cm or at most 1 cm and/or at most50% or at most 30% or at most 20% or at most 10% of a length ofventilation-tube-connector-assembly-proximal portion 598 of main body210.

In some embodiments, a location of distal end 908 of sleeve 610 is notfixed relative to main body 210. For example, main body 210 may belongitudinally slidable within the sleeve 610 at or near a location ofthe distal end 908.

In some embodiments, a location of proximal end 904 of sleeve 610 isfixed and/or longitudinally fixed relative to a proximal end 204 of mainbody 210.

In some embodiments, sleeve 610 forms a substantially air-tight sealbetween the external environment and an outer surface ofventilation-tube-connector-assembly-proximal portion 598 of main body210 and/or between the external environment and region of space outsideof an outer surface of ventilation-tube-connector-assembly-proximalportion 598 of main body 210 and within sleeve 610.

In the non-limiting example of FIGS. 4A, an input module assembly 156includes respective ports for interfacing: (i) with suction source 601(i.e. suction port 820—for example, shaped as in element 34 of FIG. 1Aor any other shape appropriate to function as a suction port), (ii) asource of pressurized fluid such as liquid or mist or any gas-liquidmixture under pressure (i.e. a port for receiving pressurized fluid from602), and (iii) inflation source 603 (i.e. a port for receiving a gasflow or liquid flow from 603—for balloon inflation). Suction source 601provides negative pressure for suctioning material out of an interior ofventilation tube 60 (e.g. material formerly attached to an interiorsurface 201 of ventilation tube 60—e.g. as biofilm)—e.g. via suctionorifice(s) 440.

In some embodiments, pressurized fluid from source 602 forced, via afluid delivery lumen 520 (not shown in FIGS. 4A-4B) may enter, via fluiddelivery orifice(s) 525, into an interstitial region inside of theventilation tube 60 and outside of the main body 210. In someembodiments, a stream of the delivered fluid passes through aninterstitial region en route to the inner surface 201 of ventilationtube 60, and is incident upon the ventilation tube inner surface 201.Delivery of the fluid (e.g. liquid or mist or any liquid-gas mixture)into the interstitial region and/or to the inner surface 201 may beuseful for cleaning the ventilation tube inner surface 201.

In some embodiments, pressurized liquid or gas delivered from inflationsource 603 is delivered to boundary-forming inflatable balloon 588inflate boundary-forming balloon 588 (e.g. to form a slidable boundaryas will be discussed below).

In the non-limiting example of FIGS. 4A-4B, the fluids source 602 (e.g.source of pressurized liquid or mist or any gas/liquid mixture) and theinflation source 603 are illustrated as two separate elements. This isnot a limitation. In other embodiments (see, for example, FIG. 14) thesource of pressurized liquid 602 may be used to both inflateboundary-forming balloon 588 and to delivery fluid via fluid deliveryorifice(s) 525.

FIGS. 4A-4B refer to the example where a source of fluids (e.g. liquidor any other liquid-gas mixture) is ‘external’ and may either be asource of liquids or a source of other fluids such as gas-liquidmixtures (e.g. mist). In the example of FIG. 4C, a gas/liquid mixturesource (e.g. a pressurized gas/liquid mixture) 698 is explicitlyillustrated and may be external to device 600.

In the example of FIGS. 4A-4B the source of liquid 602 and/or source ofa gas/liquid mixture (i.e. 602 or 698) are ‘external’ to the device—thecleaning device receives either liquid or a mixture of liquid and gas(e.g. via one or more ports). In some embodiments, the received fluid(e.g. liquid and/or gas) is pressurized.

In the example of FIG. 4D, the cleaning device 600 receives: (i) gas (orgas-liquid mixture) (e.g. pressurized) from a first source 692 and (ii)liquid (or gas-liquid mixture) (e.g. pressurized) from a second source602. These may be mixed—for example, within an ‘inlets module’ of device600 or in any other location—for example, within a chamber or mixingapparatus 696 that is directly or indirectly connected/attached (e.g.permanently attached) to main body 610. This is illustratedschematically in FIG. 4E.

In some examples, this may obviate the need to provide a source ofpressurized liquid. For example, it is possible to provide (i) a sourceof pressurized gas (or pressurized gas/liquid mixture) 692 and (ii) asource of liquids (i.e. pressurized or unpressurized) or liquid-gasmixture.

Liquids and gases may be mixed together within a mixing apparatus—forexample, the apparatus 696 illustrated in FIG. 4F which operates forexample according to the Venturi principle. The skilled artisan, afterreading the present disclosure, will realize that there are a number ofways of mixing fluid and gases—for example, to produces a pressurizedgas-liquid mixture including but not limited to techniques from the artof nebulizers (e.g. atomizers or jet nebulizers). Exemplary techniquesinclude but are not limited to atomizing techniques or ultrasonictechniques or bubbling techniques any other technique for mixing gas andliquid—e.g. to produce a liquid-gas mixture for example pressurized.

FIG. 5 is a close-up view of locations near distal end 208 of main body210 in some embodiments and in some configurations. Inflatable balloon588, suction orifice(s) 440 and fluid delivery orifice(s) are allvisible close to the distal end 208 of main body 210.

FIG. 6 illustrates the distal end of main body 210 after insertion intoventilation tube 60 having an inner surface 201. In the example of FIG.6A, inflatable balloon 588 divides the region of space within theventilation tube 60 but outside of main body 210 into two regions:

(i) A first sub-region 774 that is proximal to slidable ‘boundary’ whoselongitudinal location is identified in FIG. 6 by a dividing line 780 (itis appreciated that the dividing line 780 is only a mathematicalconstruct). This first sub-region 774 is referred to as the ‘moreproximal portion of the interstitial region outside of the main body 210and inside of ventilation tube 60;

(ii) A second sub-region 778 that is distal to dividing line 780.

In the example of FIGS. 6A, 6E (also see FIG. 10A, 11A; 16A-16C) theballoon in contact with the inner surface 201 of ventilation tube 60actually provides a seal between the first (i.e. proximal 774) andsecond (i.e. distal 778) regions. However, this is not a limitation, andin other embodiments (see, for example, FIGS. 6F-6I; 10C, 11C; 16D) itis possible for the inflated balloon to obstruct (i.e. significantlyhinder) longitudinal flow between the first (i.e. proximal 774) andsecond (i.e. distal 778) regions without forming such a seal.

The first sub-region 774 may be referred to as ‘the more proximalportion of the region within the ventilation tube and outside of mainbody’ while the second sub-region 778 may be referred to as the ‘themore distal portion of the region within the ventilation tube andoutside of main body.’

This second sub-region 778 may include: (i) locations in theinterstitial region that are distal to the slidable boundary 770; and(ii) locations in the interior of the ventilation tube that are distalto the slidable boundary 770.

In the examples of FIGS. 6A, 6B, 10A, 14A, 14B, 14C, contact balloon 588(i.e. inflatable into contact) is deployed near the distal end 208 ofmain body 210 (but not at the distal end 208), and sub-region 778A isvisible. In the examples of FIGS. 6E and 11A, inflatable balloon 588 isdeployed at distal end 208 of main body 210 and sub-region 778A isabsence. In both sets of examples, sub-region 778B is visible.

In the example of FIGS. 6, a plurality of balloons located withinventilation tube 60 (i.e., each mounted to the main body 210—e.g. at ornear a distal 208 end) include: (i) inflatable ‘first’ balloon 588 and(ii) second balloon 586 deployed to main body 210 (e.g. mounted to mainbody) which may or may not be inflatable and which functions as a‘liquid supply balloon.’ The second balloon 586 includes one or moreholes or voids which are fluid delivery orifice(s) 525 (in the exampleof FIG. 6A, four holes 525A-525D are illustrated). A pressurized liquid525 may enter, via the fluid delivery orifice(s) 525 into ‘the moreproximal portion of the region within the ventilation tube and outsideof main body’ 774 of the interstitial region proximal to inflatableballoon 588 (for example, when balloon 588 is inflated into contactand/or so as to obstruct).

In some embodiments, the delivered fluid takes the form of a stream556—for example, strong enough so that upon exit from the fluid deliveryport 525 the flowing liquid has enough momentum to reach an interiorsurface 201 of ventilation tube 60. In some embodiments, the deliveredfluid is pressurized immediately before exiting fluid delivery port 525by at least 1.5 atmospheres or at least 2 atmospheres or at least 3atmospheres.

In some embodiments, the delivered fluid is pressurized enough so thatupon exiting fluid delivery port 525 a ‘jet of fluid’ or a ‘strong jet’of fluid is obtained. In some embodiments, pressurized under apressurize of at least 1.5 atmospheres or at least 2 atmospheres or atleast 3 atmospheres exits a fluid delivery orifice having an internalwidth that is at most 1.5 mm or at most 1 mm or at most 0.75 mm or atmost 0.5 mm.

In some embodiments, the includes only a single fluid delivery orifice.Alternatively, in other embodiments, it is advantageous to employ aplurality of delivery ports. FIG. 7A illustrates four streams of liquid556A-556D respectively exit from four different fluid delivery orifices525A-525B.

In some embodiments, pressurized liquid (e.g. from a source outside ofthe ventilation tube and/or proximal to connector 158—e.g. frompressurized liquid source 602) is forced (e.g. simultaneously forced)through first 525A and second 525B fluid delivery orifices torespectively produce first 556A and second 556B fluid streams that arerespectively incident (e.g. simultaneously incident) upon an innersurface 201 of the ventilation tube 60 at first 552A and second 552Blocations. In some embodiments, the first 552A and second 552B locationsare substantially on opposite sides of the ventilation tube 60 innersurface 201 within a tolerance that is at most 75 degrees (i.e. angletheta is between 105 and 180 degrees) or within a tolerance of at most45 degrees (i.e. angle theta is between 135 and 180 degrees) or within atolerance of at most 25 degrees (i.e. angle theta is between 155 and 180degrees). Note that there is no requirement for first 552A and second552B locations to have the same longitudinal position—i.e. it ispossible to calculate theta by projecting the first and second positionsinto a plane that is perpendicular to a central axis of ventilation tube(e.g. having a longitudinal position that is the average of thelongitudinal positions of the for first 552A and second 552B locations).

Although not a limitation, in some embodiments, one or more of thestreams 556 may have enough momentum to reach an enclosing tube (e.g.ventilation tube 60). For example, any combination of the extent towhich the delivered fluid pressurized and/or the size of the orifice(i.e. smaller sizes facilitated greater fluid momentum in stream 556)may be such that, for any position of main body 210 within tube 60, whenthe local central axis 202 (i.e. in the region of locations 552A and552B) of main body 210 is perpendicular to the gravity vector, and whenthe local central axis (i.e. in the region of locations 552A and 552B)of an enclosing tube (e.g. ventilation tube 60) is parallel to gravity(e.g. both local axes are substantially straight), momentum of thedelivered fluid upon exit via orifices 525A and 525B is sufficient suchthat respective streams 556A and 556B are incident upon locations in theinner wall

For example, this may be true any position of main body 210 relative toan enclosing tube—e.g. a “reference” cylindrical tube having an innerdiameter that is at least 4 mm or at least 6 mm and/or at most 12 mm orat most 10 mm or at most 8 mm. In some embodiments, under theseconditions (e.g. both central axes parallel to the gravity vector sothat the enclosing tube and main body 210 are at least locally‘upright’, size features of the enclosing tube—e.g. ventilation tube 60)streams 556A and 556B may have enough momentum so as to be incident uponinner surface 201 of the enclosing tube at locations 552A, 552B that aresubstantially on opposite sides of the inner surface 201 of theenclosing tube 60.

Any features described with relation to FIGS. 7A-7B are not limited toembodiments of FIG. 6, and may relate to the any other embodiment.

Not wishing to be bound by any particular theory, in some embodiments,delivering a stream of fluid with sufficient momentum to be incidentupon inner surface 201 of ventilation tube 60 may be useful formechanically dislodging biofilm temporarily attached to the ventilationtube inner surface 201 and/or chemically interacting with the biofilm inorder to reduce any forces causing the biofilm to adhere to innersurface 201.

Not wishing to be bound by any particular theory, in some embodiments,ensuring that a plurality of streams are incident upon different ‘sides’of ventilation tube inner surface 201 may be useful for achieving thiseffect throughout ventilation tube inner surface 201 (e.g. forlongitudinal locations being cleaned—for example, located in a distalhalf of ventilation tube 60).

Reference is made once again to FIG. 6A. In FIG. 6A, suction orifice(s)440 is also illustrated.

As illustrated in FIG. 6A, fluid delivery orifice(s) 525 is suppliedwith pressurized liquid (e.g. from liquid source 602) via fluid deliverylumen(s) 520. In some non-limiting embodiments, pressurized liquidreceived via fluid delivery lumen(s) 520 also functions to inflatesecond balloon 586. In some embodiments, second balloon 586 isinflatable. Alternatively, second balloon 586 is not required to beinflatable.

Suction orifice(s) 440 is supplied with negative pressure from suctionsource 601 via suction lumen(s) 530.

Inflatable balloon 588 is inflated with liquid or gas received frominflation source 603 via balloon inflation lumen 585.

In some embodiments, when inflatable balloon 588 is inserted intoventilation tube 60, balloon 588 is not sufficiently inflated to contactan inner surface 201 of tube 60 and thus free longitudinal motion ofinflatable sealing balloon 588 is possible. After inflation, a slidableobstructing ‘boundary’ is created so that inflatable balloon 588 maylongitudinally move in ventilation tube 60 while in contact with thetube and/or inflated so as to ‘obstruct’ (i.e. significantly hinder)longitudinal flow. In some embodiments, inflation of balloon 588 issufficient (e.g. for at least one location of main body 588 within maintube 210) to cause contact with an enclosing ventilation tube 60 and/orto ‘obstruct flow’ with the aforementioned ‘reference’ enclosing tubehaving an inner diameter of at least 4 mm or at least 6 mm and/or atmost 12 mm or at most 11 mm or at most 10 mm or at most 8 mm.

FIG. 6C illustrates a cross section of main body 210 according to someembodiments. In some non-limiting example, lumen(s) may be embeddedwithin main body 210 and provided as elongate voids within main body210. In FIG. 6C, cross sections of three lumens are illustrated: (i) ofsuction lumen 530; and (ii) fluid delivery lumen 520 and (iii) ofballoon lumen 580 via which pressurized gas or liquid is delivered frominflation source 603 into boundary-forming inflatable balloon 588. Asnoted earlier, there is no requirement for separate sources 602, 603 forfluid delivery into proximal region 744 and for balloon inflation.Similarly, there is no requirement separate lumen 520, 580.

FIGS. 8-11 illustrates an embodiment that lacks the second balloon 586.In the example of FIGS. 8-11, suction 440 orifice(s) and fluid delivery525 orifice(s) are located on the surface of elongate main body 588. Aswas the case in the embodiments of FIGS. 4-6, (i) boundary-formingballoon 588 is inflated to form the slidable boundary between proximal774 and distal 778 regions of the interior of tube 60, (ii) pressurizedfluid (e.g. liquid or liquid-gas mixture such as a mist) enters proximalregion 774 via fluid delivery 525 orifice(s), and (iii) material issuctioned into suction 440 orifice(s) for proximal transport out ofventilation tube 60. As noted elsewhere, fluid delivery and suctioningoperations may be carried out sequentially or simultaneously. As notedelsewhere, in some embodiments, longitudinal motion of inflatedboundary-forming balloon 588 (e.g. in a proximal direction) may beuseful for wiping biofilm or other material attached to ventilation tubeinner surface 201.

In the example of FIGS. 10A-10B, balloon 588 is not mounted at thedistal end of main body 210. In the example of FIGS. 11A-11B, balloon588 is mounted at the distal end of main body 210. In differentembodiments, balloon 588 may be mounted to main body 210 at differentlocations, including locations not illustrated in the figures.

In the example of FIG. 12, boundary-forming balloon is not inflatedand/or not sufficiently inflated to form a boundary that obstructs (i.e.significantly hinders) longitudinal flow between locations proximal anddistal to balloon 588. This NON-CONTACT configuration may be useful for:(i) insertion of balloon 588 into tube 60 and/or distal motion ofballoon 588 within tube 60 to a desired or target cleaning location;(ii) operation so that material located distal to balloon 588 (e.g.within the interior of tube 60 or distal to tube 60) may be suctionedinto suction orifice(s) 440 and subsequently proximally transported outof tube 60 (e.g. within suction lumen(s) 530).

Thus, in some examples, it is possible to operate the cleaning device inmultiple modes. In the first mode (see, e.g. FIGS. 6A-6B, 6E, 10A, 11A,16A, 16B), (i) boundary-forming balloon 588 is in CONTACT mode so that‘obstructing’ boundary (i.e. to significantly hinder longitudinal flow)is maintained; and (ii) material suctioned via proximally-locatedsuction orifice(s) 440 (i.e. located proximal to boundary and/or balloon588) is restricted, by the presence of boundary, to material within theproximal portion 774 of the interstitial region. This mode may used, insome embodiments, primarily to clean biofilm adhering to and/ortemporarily attached to inner surface 201 of ventilation tube 60.

In the second mode (see FIG. 12), boundary forming balloon 588 is notsufficiently inflated to main boundary—however, proximally-locatedsuction orifice(s) 440 are used to suction material distal of balloon588 (for example, tracheo-bronchial fluids in the patient's trachea).

FIG. 13 illustrated proximal ends of various lumens. For example, it ispossible to deliver pressurized fluid (e.g. from a source 602 ofpressurized liquid or liquid-gas mixtures) through a proximal fluid port827 into pressurized fluid reservoir 820. Pressurized liquid entersfluid delivery lumens 520 via respective openings in fluid deliverylumen located near the proximal end of the fluid delivery lumen 520.

In some embodiments, reservoir 820 may function as a mixing apparatus tomix gas and liquids—e.g. to provide pressurized liquid-gas mixtures).

As noted above, there is no requirement for multiple fluid deliveryorifices 525, and some embodiments relate to the case where only asingle fluid delivery orifice 525 is present. For embodiments wherepressurized fluid (e.g. liquid or liquid-gas mixture) is distally sentto multiple fluid delivery orifices 525, it is possible to supply amultiple orifices by a single fluid delivery lumen 520 and/or to includemultiple delivery lumen(s) 520. In FIG. 13, where the device includesfive fluid delivery orifice 525, both features are illustrated. Multiple(e.g. two) fluid delivery lumen(s) are employed, and two of these lumenssupply pressurized fluid (e.g. liquid or liquid-gas mixture) to multiplefluid delivery orifices 525.

FIGS. 14-16 illustrate an embodiment of the invention where the fluiddelivery orifices are actually located on surface 589 ofboundary-forming balloon. In the non-limiting example of FIG. 4A, fluiddelivery orifice(s) 525 located on the surface of the second balloon550—for example, as voids or holes in the surface 589 of the balloon588. In some embodiments, fluid delivered via these orifice(s) 525 isrestricted to ‘proximal’ locations 774 within the interstitial regionbut proximal to boundary. As such, it may be useful to locate orifice(s)525 on a proximal part of balloon and/or to orient orifice(s) 525 todeliver fluid in a proximal direction. In some embodiments (see FIG. 7)streams of fluid are incident upon substantially different sides of theinner surface 201 of tube 60—this feature is also provided in FIGS.16A-16C.

In the example of FIG. 16A, a single balloon is provided 588. Becausethis balloon includes one or more voids/holes on its surface 589 (i.e.these function as fluid-delivery orifices), pressurized fluid (i.e.liquid or liquid-gas mixtures—for example, a liquid-gas mixture that ispredominantly liquid such as a bubbled liquid) needs to be supplied(e.g. from a source outside of tube 60 such as fluids source 602) at asufficient rate (e.g. via lumen(s) 620) to maintain sufficient inflationof balloon 588 to maintain boundary. In some embodiments, the rate ofpressurized fluid delivery to balloon 588 should, in the steady state,exceed that rate at which fluid is delivered from orifice(s) 525 inballoon surface 589 to maintain the contact between balloon 588 andinner surface 201 of tube 60.

In some embodiments, a ratio between an area of all orifice(s) 525 orvoids in a surface 589 of boundary-forming balloon 588 to the total areaof the surface 589 of boundary-forming balloon is at most 0.2 or at most0.1 or at most 0.05 or at most 0.03 or at most 0.01 and/or at least0.005 or at least 0.01 or at least 0.03 or at least 0.05.

Not wishing to be bound by theory, it is noted that in some clinicalsituations, a practitioner (e.g. nurse or doctor) needs to deflateand/or remove the balloon rather ‘quickly’—e.g. within 60 seconds or 30seconds or 15 seconds from a time that boundary is formed. This may beuseful for reducing a risk of suffocation to the patient. Not wishing tobe bound by theory, the provisioning of a single mechanism for bothpressurized fluid delivery as well as maintenance of boundary can beuseful for reducing the risk that, at the end of the procedure wherebyan inner surface 201 of tube 60 is cleaned, the practitioner remembersto ‘shut off’ the fluid delivery but neglects to deflateboundary-forming balloon 588.

In some embodiments (see FIG. 14), it is no longer necessary to includeseparate pressurized fluid 602 and inflation 603 sources—it issufficient to provide a single source for fluid delivery and forinflation.

In one variation (see FIG. 16B), it is possible to include a balloonwithin a balloon. For example, the inner balloon may be supplied withliquid or with a gas or a mixture thereof, and may have a separatefluids supply (and/or lumen(s)) than that of the outer balloon. Inanother variation (see FIG. 16C), a single balloon may include multiplecompartments which are supplied by a common fluid supply and/or lumen orby separate supplies and/or lumens.

For the example of FIG. 16C, the proximal compartment includes fluiddelivery orifice(s) 525, while the distal compartment lacks suchorifices. The device may be operated in multiple modes. In one mode,distal compartment is sufficiently inflated (e.g. with gas or fluid) toform boundary. In this mode, delivery of fluid via fluid orifice(s) 525in the proximal compartment is not needed to maintain the contact.

In a second mode, the distal compartment is not inflated or notsufficiently inflated to form boundary. In this mode, the device mayprovide features similar to those observed in the embodiment of FIG.16A.

FIG. 17A illustrates yet another embodiment. In the example of FIG. 17A,a common fluids source 602 supplies fluid (e.g. liquid-containing fluid)to both balloon 588 and fluids delivery orifice 525. In someembodiments, common fluids source 602 is pressurized.

FIG. 17B illustrates an embodiment wherein a single fluids lumen 520supplies both fluids delivery lumen 520 and an interior of balloon 588with fluid (e.g. liquid and/or gas—for example, a pressurized fluid suchas a pressurized liquid). The fluid travels within lumen 520—at location516, a first portion of the fluid that has traveled within lumen 520continues in a distal direction into balloon 588 to inflate balloon 518;a second portion of the fluid that has traveled within lumen 520 exitsinto proximal portion 774 of the interstitial region via fluid deliveryorifice 525.

Although not a limitation, the balloon as illustrated in FIGS. 17A-17Bis sealed and is not leaky—this is in contrast to the balloon of FIG.16A which is leaky and has voids/holes therein.

In some embodiments related to FIGS. 17A and/or 17B, one or more of(i.e. any combination) the following features may be provided: (i) asingle lumen 520 or a single fluids source 602 supplies fluid to fluiddelivery orifice 525 and to inflatable balloon 588; and/or (ii) a singlelumen 520 or a single fluids source 602 supplies fluid to fluid deliveryorifice 525 and to an inflatable non-leaky or sealed balloon 588; and/or(iii) a single lumen 520 or a single fluids source 602 supplies fluid toinflatable balloon 588 and to a fluid delivery orifice 525 not locatedon balloon 588 (e.g. proximal to balloon 588—e.g. by at least 3 mm or atleast 5 mm or at least 1 cm).

In the example of FIG. 17A, parallel lumens 580 and 520 respectivelyleading to an interior of balloon 588 and to fluid delivery orifice 525are supplied with fluid (e.g. pressurized fluid—e.g. pressurized liquidor mist) by a common fluid source.

In the example of FIG. 17B, a single lumen supplies fluid (e.g.pressurized fluid) to both balloon 588 and to fluid delivery orifice525.

FIGS. 18-22 relate to an embodiment whereby cleaning device includes a‘mist-formation assembly.’ In the examples of FIGS. 18-22, a mist isformed by combining (i) a gas or gas-rich fluid (e.g. from fluid source602A) and (ii) a liquid or liquid-rich fluid (e.g. from fluids source602B). In some embodiments, the gas or gas-rich fluid is received into afirst fluid-delivery lumen 520A (e.g. via port 822) and the liquid orliquid-rich fluid is received into a second fluid-delivery lumen 520B(e.g. via port 824). Upon mixing (i.e. at a mixing location—see forexample mixing location 522 of FIG. 19A) between the two fluids, theliquid or liquid-rich fluid forms droplets which are suspended withinthe gas of or the gas-rich fluid, thereby forming the mist.

In some embodiments, the gas or gas-rich fluid is pressurized and/orflowing in a distal direction at some sort of ‘significant flowvelocity’ upon exiting second fluid delivery lumen 520B via fluiddelivery orifice 224 to mixing location 522. In some embodiments, thereis no need for the fluids (e.g. the liquid or liquid-rich fluids) withinthe first fluid delivery lumen 520A or fluids of liquids-rich fluidssource 602B to be pressurized. For example, the flow velocity of gas orgas-rich fluids at mixing location 522 (e.g. which is also ‘close to’ afluid delivery orifice 244 via which fluids exit first fluid deliverylumen 520A) may be sufficient to induce distal motion of liquid or aliquids-rich fluid within the first fluid delivery lumen 520A to themixing location 522 where the droplets are formed from liquid andsuspended in the gas (or gas-rich fluid) flow to form the mist.

In the examples of FIG. 19A-19B, the mist may be formed at or below asurface of main body 210 or ‘within main body 210’ (e.g. at a locationwithin ventilation tube 210). In the example of FIG. 20, the mist may beformed within the proximal portion 774 of interstitial region.

For both cases or for any other embodiment where mist is generated ‘insitu’ (i) at a location within main body 210 (e.g. within main body 210at a location within ventilation tube); and/or (ii) at a location withinproximal portion 774 of interstitial region, it may be useful to arrangefluid delivery lumens 224 and 244 to be ‘close to each other’—i.e. sothat a distance between ‘closest locations’ of fluid delivery lumens 224and 244 (not a ‘center-center distance’) is at most 5 mm or at most 4 mmor at most 3 mm or at most 2 mm or at most 1 mm.

FIGS. 21A-21C are cross-sections of a main body 210 of a deviceincluding a mist-formation assembly according to some embodiments. Insome embodiments, within a cross section of main body 210 the fluiddelivery lumens 520A, 520B are ‘close to each other’ so that closestlocations thereof are separated by at most 5 mm or at most 4 mm or atmost 3 mm or at most 2 mm or at most 1 mm.

FIG. 22 is a more schematic illustration of a cleaning device includinga mist formation assembly. In some embodiments, the mist formationassembly is operative, when the main body 210 is inserted through thetube-connector assembly 158 into the ventilation tube 60, to form a mistfrom a liquid or a liquid-rich fluid and a gas or a gas-rich fluid (e.g.supplied by respective sources 602B and 602A) so that the formed mistflows within a proximal portion 774 of the interstitial region that isproximal of to balloon 588.

As noted earlier, inflatable balloon 588 is just one example of awidth-expandable wiping element.

Another example of a width-expandable wiping element is illustrated inFIGS. 23A-23B. The ‘width-expandable’ wiping element is expandable in awidth direction defined by the elongated body 210—i.e. expandable incross-section plane or a plane perpendicular to an elongate or centralaxis 202 of elongated body 210.

Inflatable balloon 588 is one example of the width-expandable wipingelement—when inflated, balloon 588 may make contact with an innersurface 201 of ventilation tube 60.

Another example of a width-expandable wiping element 588 is illustratedrespectively in compressed and expanded configuration respectively inFIGS. 23A-23B. For example, in FIGS. 23A-23B or in other embodiments,the wiping element 380 may be outwardly biased—when within a lumen ofmain body (see FIG. 23A—the lumen functions as a ‘sheath’) theoutwardly-biased element may be constrained within the lumen so that thewidth (i.e. in a direction perpendicular to a central axis or elongateaxis of main body 210) is relatively ‘small’ This compressedconfiguration is illustrated in FIG. 23A.

In some embodiments, the wiping element 380 or 588 (e.g.outwardly-biased wiping element) may include a so-called shape-memorymaterial. For example, the wiping element may be pre-shaped into aspiral shape as shown in FIGS. 23A-23B. In FIG. 23A, the wiping elementis ‘compressed’ within main body 210—in FIG. 23B, the wiping element ismoved distally relative to the ‘sheath’ or ‘lumen’ of main body. In thiscase, the wiping element expands to or towards its ‘equilibriumshape’—in this case, a spiral shape. The spiral-shaped wiping element380 may be contact with an interior wall 201 of ventilation tube 60, andjust like was seen for the balloon-related examples, longitudinal motionof wiping element 380 may wipe material on the interior wall 201 ofventilation tube 60—for example, biofilm. The wiping element may alsodefine a ‘boundary’ between proximal 774 and distal 778 portions of theinterior of ventilation tube 60.

Since, in some embodiments, an inflatable balloon 588 is a special caseof a width-expandable wiping element, any element which may be‘proximal’ to a balloon 588 may, in some embodiments, be proximal to anywidth-expandable wiping element, including balloons 588 orwidth-expandable wiping elements other than balloons (e.g. see FIGS.23A-23B or any other width-expandable wiping element).

Unless indicated to the contrary, in any embodiment illustrated hereinin the contact of an inflatable balloon 588 (e.g. a ‘boundary-forming’balloon 588), it is possible to substitute any width-expandable wipingelement including those other than balloons instead.

In some embodiments it is possible to manually regulate the suctioningand fluid delivery operations that are carried out within ventilationtube 60 using suction 440 and fluid delivery 525 orifices. In theexample of FIG. 24A, a switching assembly is provided—for example, toregulate behavior of a valve, Fluids switch 6022 regulates fluiddelivery and suction switch 6011 regulates suction. In some embodiments,it is possible to easily and simultaneously control both switches. Forexample, a single or common switch 699 may regulate both fluid deliveryand suctioning —see for example, FIG. 24B. In some embodiments, any oneof these switches, or both of these switches are biased to an ‘off’position where there, substantially, is no suction and/or no fluiddelivery.

In some embodiments, source 602 of pressurized fluid may include asyringe assembly—when the syringe is depressed, this distally forcesfluid (e.g. liquid or a mist) into ventilation tube via the fluiddelivery lumen.

Alternatively or additionally, a continuous (i.e. constant ornon-constant) source of suction 601 or pressurized fluid 602 may beprovided.

The example of FIG. 25 relates to the case where a balloon 588 (e.g.configured as a ‘boundary-forming’ balloon and/or as a width-expandablewiping element) is operatively linked to and/or in fluid communicationwith a balloon inflation indicator or meter 663 which indicates a degreeto which boundary-forming balloon 588 (i.e. configured as awidth-expandable wiping element). In FIG. 25, this is illustrated forthe case of an inflation source 603 separate from fluids source602—however, this is not a limitation and it is possible also to meteror measure a degree of balloon inflation when the same fluids source 602supplies fluids both to fluid delivery orifice 525 and boundary-formingballoon 588.

In one non-limiting embodiment, the balloon inflation indicator or meter663 is itself a balloon in fluid communication with boundary-formingballoon 588 (i.e. configured as a width-expandable wiping element).

In various examples described above, suctioning was restricted byslidable boundary to locations, within the interior of the tube. In someembodiments, concurrent with the maintaining of the slidable boundary,there is no suctioning carried out distal to the slidable boundaryand/or only a “small” amount of suction relative to the suctioning ofmaterial from proximal locations 774 via suctioning orifice(s) 440. Forexample, a ratio between the ‘suctioning flow’ rate of material from thedistal locations 778 to the ‘suctioning flow’ rate of material from theproximal 774 locations may be at most 0.25 or at most 0.2 or at most 0.1or at most 0.05.

One feature provided by some embodiments is that when boundary-formingballoon 588 is inflated so that boundary is maintained, there is littleor no suction/negative pressure applied to locations 778 distal of theboundary. Not wishing to be bound by any theory, the inventors presentlybelieve that application so such ‘distal’ suction while boundary ismaintained may reduce an amount of air available to the patient and/orlocated in the patient's trachea precisely during the short period oftime when the balloon 588/boundary block air from the ventilator fromreaching the patient's lungs.

FIGS. 26A-26C describes a manufacturing technique which, in somenon-limiting embodiments, is useful to facilitating this feature. Duringan earlier stage of manufacturing (HG. 26A), suction lumen 520 and/orsuction orifice(s) 440 is in fluid communication with a distal opening519 which is located distal of the balloon mounting location 587 towhich balloon 588 is mounted (for example, mounted at a later time).During a later stage of manufacturing, it is possible to completely (seeFIG. 26B) or at least partially (see FIG. 26C) block this opening 519.There is no limitation on how this may be accomplished—appropriatetechniques include melting the lumen (e.g. near opening 519) so as toclose opening 519 or introduction of glue or any other foreign materialsinto 520 (e.g. near 519). Blocking of 519 creates some sort of ‘blockingelement’ or ‘blocking structure’ which partially or completely blocksopening 519.

In some embodiments, after balloon 588 is inflated to create boundary,an interior of suction lumen 520 (e.g. at a ‘half-way’ location halfwaybetween proximal 204 and distal 208 ends of main body 210 and/or at alocation that is 3 cm or 5 cm or 10 cm proximal to balloon mountinglocation 587 or balloon 588) and/or one or more or all of suctionlumen(s) 440 (e.g. located proximal to balloon mounting location 587) isnot in substantially fluid communication with any location 778 outsideof main body 210 and distal to boundary and/or is only in fluidcommunications with one or more opening(s) 519 whose total aggregatesize is relatively ‘small’ relative to an aggregate size of suctionport(s) 440 open to proximal locations 774 and/or located proximal tomounting location 587 or balloon 588.

This, in exemplary embodiments, the device is configured, when sleeve770 is maintained, to substantially restrict suction/negative pressureto proximal locations 774—for example, at most 30% or at most 20% or atmost 10% of a total negative pressure applied within an interior of tube60 and/or applied via suction lumen 520 and/or via all suction lumen(s)520 within or along main body 210 is applied to distal locations778—i.e. a significant majority or an entirety of the negative pressureis restricted (i.e. by the presence of inflatable balloon 588 whichmaintains the ‘obstructing boundary’) to proximal location(s) 774.

In some embodiments, one or more of the suction orifice(s) 440 (e.g.proximal to mounting location 587 or balloon 588 or boundary and/or opento proximal locations 774) (e.g. which is supplied or primarily suppliedwith negative pressure via suction lumen(s) 520) is in fluidcommunication, through suction lumen 520, with a ‘blocking element’ or‘blocking structure’ which partially or completely blocks opening 519.

Some additional features (e.g. related to numerical parameters) arediscussed in the present section. As with all features, they areintended as exemplary and not as limiting.

There is no limitations on the material from which any element (e.g.main body, lumen(s), orifice(s), balloon, etc) may be constructed. Innon limiting embodiments, material used may include, but are not limitedto biocompatible materials, polymer-based materials, plastics, silicone,polyurethane and latex. As the skilled artisan will appreciated afterreading the present disclosure, other materials may be used.

In various embodiments (not limited to the embodiments of FIG. 4A or inany other figure), there is no particular limitation on the size of thefluid delivery orifice(s) 525 and/or suction 440 orifice(s).

In some embodiments, an average suction lumen(s) 520 width (e.g.averaged over a longitudinal direction) is between 2 and 5 mm. In someembodiments, an average fluid delivery lumen(s) 530 width (e.g. averagedover a longitudinal direction) is at most 0.75 or at most 0.5 or at most0.25 or at most 0.2 or at most 0.15 or at most 0.1 times an averagesuction lumen(s) 520 width.

In some embodiments, an inner width of one or more of the fluid deliveryorifice(s) 525, or an average orifice inner width for any number (i.e. 2or 3 or 4 or any other number) of fluid delivery orifice(s) 525 is atmost 3 mm or at most 2 mm or at most 1 mm or at most 0.75 mm or at most0.5 mm and/or at least 0.25 mm or at least 0.5 mm or at least 1 mm.

In some embodiments, an inner width of one or more of the suctionorifice(s) 440, or an average orifice inner width for any number (i.e. 2or 3 or 4 or any other number) of suction orifice(s) 440 is at most 7 mmor at most 3 mm or at most 2 mm and/or at least 0.5 mm or at least 1 mmor at least 2 mm or at least 3 mm or at least 4 mm.

In some embodiments, an inner width of one or two or three or any numberof fluid delivery orifice(s) 525 is at most 50% or at most 30% or atmost 20% or at most 15% of an inner width of one or two or three or anynumber of suction orifice(s) 440.

In some embodiments, one or more of the suction 440 and/or fluiddelivery 525 orifice(s) is deployed at most 5 cm or at most 3 cm or atmost 2 cm or at most 1 cm proximal to a balloon mounting location 770and/or an average or proximal location of boundary-forming balloon 588and/or a location of boundary.

In some embodiments, an cross section of the suction lumen 530 exceeds across section of fluid delivery lumen 530 by a factor of at least 1.5 ora factor of at least 2 or a factor of at least 4 or a factor of at least5 or a factor of between 6 and 15 or a factor of between 8 and 12.

It is now disclosed a ballooned cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)602 of pressurized liquid and a source(s) of suctioning 603, thecleaning device comprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a balloon 588 mounted to the main body 210 at a location in thedistal half of the main body and inflatable into contact with an innersurface 201 of the ventilation tube 60;

d. one or more liquid-delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport pressurized liquidreceived from pressurized liquid source(s) outside of the ventilationtube 60, into a proximal portion 774 of the interstitial region that isproximal of the balloon 588 so that the transported liquid enters theproximal portion 774 via liquid delivery orifice(s) 525 located on ormechanically coupled to the main body 210;

e. suction lumen(s) 530 arranged within or along the main body 210, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210;

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

In some embodiments, at least one of the fluid delivery orifice(s) 525is a void in the balloon 588 so that the balloon 588 is leaky.

In some embodiments, the inflatable balloon is operative to be inflatedby pressurized fluid source via fluid delivery lumen(s) 520.

In some embodiments,

i. inflatable balloon 588 is a leaky balloon having one or moresurface-located leak holes; and

ii. one or more of the fluid delivery orifice(s) 525 are leak holes thatface in a direction having a proximal component; and

iii. inflatable balloon is operative to be inflated by pressurized fluidsource via fluid delivery lumen(s) 520.

In some embodiments,

i. balloon 588 is a boundary-forming balloon which divides an interiorof the ventilation tube into more proximate 774 and more distal 778portions;

ii. at least one of the at least one of the fluid delivery orifice(s)525 is a void in the boundary-forming balloon 588 so that theboundary-forming balloon 588 is leaky;

iii. forcing of pressurized liquid into the boundary-forming balloon 588is operative both:

-   -   A. to inflate boundary-forming balloon 588;    -   B. to cause the pressurized liquid to enter the proximal portion        774 via liquid delivery orifice(s) 525 located on or        mechanically coupled to the main body 210.        In some embodiments, the boundary-forming balloon 588 forms a        seal between the proximate 774 and distal 778 portions of the        interstitial region.        In some embodiments, the boundary-forming balloon 588 does not        form a seal between the into proximate 774 and distal 778        portions of the interstitial region.        In some embodiments, the balloon 588 hinders and/or at least        partially obstructs fluid communications between the more        proximal and more distal portions.        It is now disclosed a cleaning device for use with an ETT or        tracheostomy ventilation tube 60, a ventilator machine 900, a        source(s) of fluid and a source(s) of suctioning 603, the        cleaning device comprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a balloon 588 mounted to the main body 210 at and inflatable intocontact with an inner surface 201 of the ventilation tube 60;

d. one or more fluid delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport pressurized fluidreceived from pressurized fluid source(s) outside of the ventilationtube 60, into a proximal portion 774 of the interstitial region that isproximal of the balloon 588 so that the transported fluid enters theproximal portion 774 via fluid delivery orifice(s) 525 located on ormechanically coupled to the main body 210;

e. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a ballooned cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a balloon 588 mounted to the main body 210 at and inflatable intocontact with an inner surface 201 of the ventilation tube 60;

d. one or more fluid delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport fluid received fromfluid source(s) outside of the ventilation tube 60, into a proximalportion 774 of the interstitial region that is proximal of the balloon588 so that the transported fluid enters the proximal portion 774 viafluid delivery orifice(s) 525 located on or mechanically coupled to themain body 210;

e. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a ballooned cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a balloon 588 mounted to the main body 210 at a location inflatableinto contact with an inner surface 201 of the ventilation tube 60;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210;

e. a fluid delivery orifice(s) in fluid communication with a proximalportion 774 of the interstitial region that is proximal of the balloon588 so that the fluid from the fluid source passing through the fluiddelivery orifice enters the proximal portion 774;

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a ballooned cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, and asource(s) of suctioning 603, the cleaning device comprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a balloon 588 mounted to the main body 210 at a location inflatableinto contact with an inner surface 201 of the ventilation tube 60;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210;

e. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

f. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a ballooned cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. an elongate, flexible, main body 210 that into the ventilation tube60 to form an interstitial region outside of the main body 210 withinventilation tube 60;

b. an inflatable balloon 588 mounted to the main body 210 and inflatablewhen within the ventilation tube 60;

c. one or more fluid delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport fluid received fromfluid source(s) outside of the ventilation tube 60, into a proximalportion 774 of the interstitial region that is proximal of the balloon588 so that the transported fluid enters the proximal portion 774 viafluid delivery orifice(s) 525 located on or mechanically coupled to themain body 210;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603 viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

It is now disclosed a ballooned cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. an elongate, flexible, main body 210 that into the ventilation tube60 to form an interstitial region outside of the main body 210 withinventilation tube 60;

b. an inflatable balloon 588 mounted to the main body 210 and inflatabletowards an inner surface 201 the ventilation tube 60;

c. a fluid delivery orifice(s) 525 in fluid communication with aproximal portion 774 of the interstitial region that is proximal of theballoon 588 so that the fluid from the fluid source passing through thefluid delivery orifice enters the proximal portion 774;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603 viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

In some embodiments, the balloon 588 is inflatable into contact with aninner surface 201 of the ventilation tube 60

In some embodiments, further comprising at least one of:

i. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;and/or

ii. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s).

In some embodiments, the main body is insertable through thetube-connector assembly 158 into the ventilation tube 60 and/or thefluid delivery orifice is located on or mechanically coupled to the mainbody 210.

In some embodiments, further comprising a pliable sleeve 610 around atleast a portion of the main body 210 in locations proximal to thetube-connector assembly 158 and distal to the suction port 830 toinhibit contamination.

In some embodiments, the balloon is fluid-inflatable, and the device isconfigured so that for a given fluid delivery lumen 520, a first portionof fluid flowing through the given fluid delivery lumen enters into theproximal portion 774 after passing through fluid delivery orifice(s)525, and a second portion of fluid flowing through the given fluiddelivery lumen inflates balloon 588.In some embodiments, balloon 588 is leaky and fluid delivery orifice(s)that is supplied by fluid via the given fluid delivery lumen 520 islocated on a surface 589 of balloon 588. In some embodiments, theballoon 588 is sealed and fluid delivery orifice(s) that is supplied byfluid via the given fluid delivery lumen 520 is not located on a surface589 of balloon 588.In some embodiments, fluid delivery orifice(s) that is supplied by fluidvia the given fluid delivery lumen 520 is located proximal to balloon588.It is now disclosed a cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a width-expandable wiping element 588 mounted to the main body 210and width-expandable in a direction perpendicular to an elongate axis ofthe main body 210 into contact with an inner surface 201 of theventilation tube 60;

d. one or more fluid delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport fluid received fromfluid source(s) outside of the ventilation tube 60, into a proximalportion 774 of the interstitial region that is proximal of the wipingelement 588 so that the transported fluid enters the proximal portion774 via fluid delivery orifice(s) 525 located on or mechanically coupledto the main body 210;

e. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when wiping element 588 is expanded into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210;

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a width-expandable wiping element 588 mounted to the main body 210and width-expandable in a direction perpendicular to an elongate axis ofthe main body 210 into contact with an inner surface 201 of theventilation tube 60;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when the width-expandable wiping element 588 isexpanded into contact, suction orifice(s) 440 being open to the proximalportion 774 and mechanically coupled to the main body 210;

e. a fluid delivery orifice(s) in fluid communication with a proximalportion 774 of the interstitial region that is proximal of the wipingelement 588 so that the fluid from the fluid source passing through thefluid delivery orifice enters the proximal portion 774;

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a width-expandable wiping element 588 mounted to the main body 210and width-expandable in a direction perpendicular to an elongate axis ofthe main body 210 into contact with an inner surface 201 of theventilation tube 60;

d. first 220 and second 240 fluid delivery lumen(s) arranged within oralong the elongated main body, and operative to transport fluid,received respectively from first and second fluid source(s) outside ofthe ventilation tube 60, into a proximal portion 774 of the interstitialregion that is proximal of the wiping element 588 so that the:

-   -   (i) transported fluid from both fluid delivery lumen(s) enters        the proximal portion 774 via a common fluid delivery orifice(s)        225 located on or mechanically coupled to the main body 210; or    -   (ii) fluid respectively transported through the first 220A and        second 220B fluid delivery lumen(s) respectively enters the        proximal portion 774 via first 224 and second 244 orifices that        are separated from each other by at most 5 mm and that are each        located on or mechanically coupled to the main body 210;

e. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when wiping element 588 is expanded into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210;

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

It is now disclosed a cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, an array offluid sources and a source(s) of suctioning 603, the cleaning devicecomprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a width-expandable wiping element 588 mounted to the main body 210and width-expandable in a direction perpendicular to an elongate axis ofthe main body 210 into contact with an inner surface 201 of theventilation tube 60;

d. a mist formation assembly operative, when the main body 210 isinserted through the tube-connector assembly 158 into the ventilationtube 60, to form a mist from a liquid-containing fluid and agas-containing fluid so that the formed mist flows within a proximalportion 774 of the interstitial region that is proximal of the wipingelement 588

e. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when wiping element 588 is expanded into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210;

f. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 830 to inhibit contamination.

In some embodiments, the mist is formed within the proximal portion 774of the interstitial region.

In some embodiments, the mist is formed within the main body 210.

In some embodiments, when the main body is inserted through thetube-connector assembly 158 into the ventilation tube 60 to form theinterstitial region, the mist is formed within the main body inlocation(s) within ventilation tube 60.

In some embodiments, the device is configured so that the mist entersthe proximal portion 774 of the interstitial region via a fluid deliveryorifice(s) open thereto, the fluid delivery orifice(s) beingmechanically coupled to main body 210.

In some embodiments, the mist formation assembly includes first andsecond fluid-delivery lumen(s) arranged within or along the elongatedmain body and respectively operative to receive and transport theliquid-containing and gas-containing fluids.

In some embodiments, the mist formation assembly includes a commonorifice via which material transported within the first and secondfluid-delivery lumen(s) enters into the proximal portion 774 of theinterstitial region.

In some embodiments, the first and second fluid-delivery lumen(s) mergewithin main body 210 at a merge or mixing location 522.

In some embodiments, wherein the mist is formed as fluid(s) flow fromthe merge location to or through a fluid delivery orifice, mechanicallycoupled to main body 210 and open to the proximal portion 774 of theinterstitial region.

In some embodiments, the first 224 and second 244 orifices are separatedfrom each other by at most 4 mm or at most 3 mm or at most 2 mm or atmost 1 mm.

It is now disclosed a cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. an elongate, flexible, main body 210 that into the ventilation tube60 to form an interstitial region outside of the main body 210 withinventilation tube 60;

b. a width-expandable wiping element 588 mounted to the main body 210and width-expandable in a direction perpendicular to an elongate axis ofthe main body 210;

c. one or more fluid delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport fluid received fromfluid source(s) outside of the ventilation tube 60, into a proximalportion 774 of the interstitial region that is proximal of the wipingelement 588 so that the transported fluid enters the proximal portion774 via fluid delivery orifice(s) 525;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603 viasuction orifice(s) 440 when wiping element 588 is expanded into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

It is now disclosed a cleaning device for use with an ETT ortracheostomy ventilation tube 60, a ventilator machine 900, a source(s)of fluid and a source(s) of suctioning 603, the cleaning devicecomprising:

a. an elongate, flexible, main body 210 that into the ventilation tube60 to form an interstitial region outside of the main body 210 withinventilation tube 60;

b. a width-expandable wiping element 588 mounted to the main body 210and width-expandable in a direction perpendicular to an elongate axis ofthe main body 210;

c. a fluid delivery orifice(s) 525 in fluid communication with aproximal portion 774 of the interstitial region that is proximal of thewiping element 588 so that the fluid from the fluid source passingthrough the fluid delivery orifice enters the proximal portion 774;

d. suction lumen(s) 530 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603 viasuction orifice(s) 440 when wiping element 588 is expanded into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

In some embodiments, the width-expandable wiping element 588 isexpandable into contact with an inner surface 201 of the ventilationtube 60 In some embodiments, further comprising at least one of:

i. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;and/or

ii. a suction port 830 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s).

In some embodiments, the main body is insertable through thetube-connector assembly 158 into the ventilation tube 60 and/or thefluid delivery orifice is located on or mechanically coupled to the mainbody 210.

In some embodiments, further comprising a pliable sleeve 610 around atleast a portion of the main body 210 in locations proximal to thetube-connector assembly 158 and distal to the suction port 830 toinhibit contamination.

In some embodiments, the width-expandable wiping element is aninflatable object that width-expands upon inflation.

In some embodiments, the width-expandable wiping element is a balloonthat width-expands upon inflation.

In some embodiments, the balloon 588 is inflatable via a balloon lumen580 along or within main body 210.

In some embodiments, the balloon 588 is inflatable via one of the fluiddelivery lumen(s) 520 along or within main body 210.

In some embodiments, the width-expandable wiping element is expands by amechanism other than inflation.

In some embodiments, the width-expandable wiping element includes anoutwardly biased element.

In some embodiments, the width-expandable wiping element includes anoutwardly-biased shape memory device.

In some embodiments, when in an expanded configuration, theoutwardly-biased shape memory is shaped as a spiral.

In some embodiments, when in the expanded configuration, theoutwardly-biased shape memory is pre-shaped as a spiral having a centralaxis that is substantially parallel to an elongate axis of the main body210.

In some embodiments, the outwardly biased element is a stent.

In some embodiments, the width-expandable wiping element is notoutwardly biased.

In some embodiments, the width-expandable wiping element includes arigid skeleton having a multiple configuration.

In some embodiments, a width ratio between:

i. an expanded-configuration width of the width-expandable wipingelement; and

i. a contracted-configuration width of the width-expandable wipingelement is at least 1.5.

In some embodiments, a contracted-configuration width of thewidth-expandable wiping element is at most one-half of an inner diameterof the ventilation tube 60.

In some embodiments, a contracted-configuration width of thewidth-expandable wiping element is at most one-third of an innerdiameter of the ventilation tube 60.

In some embodiments inflatable balloon 588 and fluid delivery orifice525 are supplied by a common fluid supply.

In some embodiments, inflatable balloon 588 and fluid delivery orifice525 are supplied by a common fluid supply via a common fluid deliverylumen 520.

In some embodiments, inflatable balloon 588 and fluid delivery orifice525 are supplied by a common fluid supply respectively via first 520Aand second 520B fluid delivery lumen.

In some embodiments, balloon 588 or swiping element 588 are mounted tothe main body 210 in a distal half thereof.

It is now disclosed a system comprising:

any device described herein; and

source(s) of pressurized liquid 602, the device and liquid sourceconfigured, when the main body 210 is inserted within the ventilationtube 60, such that the pressurized liquid received from the fluid(s)source or a derivative thereof enters proximal portion 774 after passingthrough fluid delivery orifice(s).

It is now disclosed a system comprising:

any device described herein; and

source(s) of liquid 602, the device and liquid source configured, whenthe main body 210 is inserted within the ventilation tube 60, such thatthe liquid received from the fluid(s) source or a derivative thereofenters proximal portion 774 after passing through fluid deliveryorifice(s).

It is now disclosed a system comprising:

any device described herein; and

source(s) of pressurized fluid 602, the device and fluid sourceconfigured, when the main body 210 is inserted within the ventilationtube 60, such that the pressurized fluid received from the fluid(s)source or a derivative thereof enters proximal portion 774 after passingthrough fluid delivery orifice(s).

It is now disclosed a system comprising:

any device described herein; and

source(s) of fluid 602, the device and liquid source configured, whenthe main body 210 is inserted within the ventilation tube 60, such thatthe fluid received from the fluid(s) source or a derivative thereofenters proximal portion 774 after passing through fluid deliveryorifice(s).

In some embodiments, the fluid(s) source includes a source ofunpressurized fluid.

In some embodiments, a mist is formed from a liquid-containing sourceand a gas containing source within main body 210 and is delivered intoenters proximal portion 774.

In some embodiments, a mist is formed from a liquid-containing sourceand a gas containing source upon entry into proximal portion 774.

It is now disclosed a method comprising employing any device or systemdisclosed herein to clean bio film from the inner surface 201 of theventilation tube.

It is now disclosed a method comprising employing any device or systemdisclosed herein to prevent accumulation or hinder accumulation ofbiofilm from the inner surface 201 of the ventilation tube.

It is now disclosed a method of cleaning a main lumen of an ETT ortracheostomy ventilation tube 60 and/or hindering accumulation of biofilm on an inner surface of ventilation tube 60, the method comprising:

at a time when:

-   -   i. a ventilation machine 900 is connected to the ventilation        tube 60 via a tube connector assembly 158 in a substantially        air-tight manner;    -   ii. an elongate, flexible, main body 210 traverses an interior        of the tube connector assembly 158 so that a distal end of the        main body 210 is located within the ventilation tube 60 to form        an interstitial region outside of the main body 210 and within        the ventilator tube;    -   iii. an inflatable balloon 588 mounted to the main body 210 is        located within the ventilation tube 60;    -   iv. sources of fluid 602 and suction 603 are respectively in        fluid communication with fluid delivery orifice(s) 525 and        suction orifice(s) 440, the suction 440 orifice(s) being located        proximal to balloon 588 within ventilation tube 60 and on main        body 210 or mechanically coupled to main body 210,

carrying out the following:

-   -   inflating the balloon 588 outwardly towards an inner surface 201        of the ventilation tube 60 and/or into contact with the inner        surface 201 of the ventilation tube 60 so that both suction 440        and fluid delivery 525 orifice(s) are in fluid communication to        a proximal portion 774 of the interstitial region that is        proximal to inflatable balloon 588;    -   concurrent with a maintaining the balloon in an inflated state,        conveying negative pressure from the suction source(s) 603, via        the suction lumen(s) 530 and orifice(s) 440, predominantly into        the proximal portion 774 of the interstitial region; and    -   concurrent with a maintaining of the balloon in the inflated        state, sending fluid from the fluid source(s) 602 through the        fluid delivery orifice(s) 525 into the interstitial region        proximal portion 774.        It is now disclosed a method of cleaning a main lumen of an ETT        or tracheostomy ventilation tube 60 and/or hindering        accumulation of biofilm on an inner surface of ventilation tube        60, the method comprising:

at a time when:

-   -   i. a ventilation machine 900 is connected to the ventilation        tube 60 via a tube connector assembly 158 in a substantially        air-tight manner;    -   ii. an elongate, flexible, main body 210 traverses an interior        of the tube connector assembly 158 so that a distal end of the        main body 210 is located within the ventilation tube 60 to form        an interstitial region outside of the main body 210 and within        the ventilator tube;    -   iii. an inflatable balloon 588 mounted to the main body 210 is        located within the ventilation tube 60;    -   iv. sources of fluid 602 and suction 603 are respectively in        fluid communication with fluid delivery orifice(s) 525 and        suction orifice(s) 440, the suction 440 orifice(s) being located        proximal to balloon 588 within ventilation tube 60 and on main        body 210 or mechanically coupled to main body 210,

carrying out the following:

-   -   inflating the balloon 588 into contact with the inner surface        201 of the ventilation tube 60 so that both suction 440 and        fluid delivery 525 orifice(s) are in fluid communication to a        proximal portion 774 of the interstitial region that is proximal        to inflatable balloon 588;    -   concurrent with a maintaining the balloon inflated into contact,        conveying negative pressure from the suction source(s) 603, via        the suction lumen(s) 530 and orifice(s) 440, predominantly into        the proximal portion 774 of the interstitial region; and    -   concurrent with a maintaining of the balloon inflated into        contact, sending fluid from the fluid source(s) 602 through the        fluid delivery orifice(s) 525 into the interstitial region        proximal portion 774.        It is now disclosed a method of cleaning a main lumen of an ETT        or tracheostomy ventilation tube 60 and/or hindering        accumulation of biofilm on an inner surface of ventilation tube        60, the method comprising:

at a time when:

-   -   i. a ventilation machine 900 is connected to the ventilation        tube 60 via a tube connector assembly 158 in a substantially        air-tight manner;    -   ii. an elongate, flexible, main body 210 traverses an interior        of the tube connector assembly 158 so that a distal end of the        main body 210 is located within the ventilation tube 60 to form        an interstitial region outside of the main body 210 and within        the ventilator tube;    -   iii. a width-expandable wiping element 588 mounted to the main        body 210 is located within the ventilation tube 60;    -   iv. sources of fluid 602 and suction 603 are and are        respectively in fluid communication with fluid delivery        orifice(s) 525 and suction orifice(s) 440, the suction 440        orifice(s) being located proximal to wiping element 588 within        ventilation tube 60 and on main body 210 or mechanically coupled        to main body 210,

carrying out the following:

-   -   expanding the mounted width-expandable wiping element 588        towards an inner surface 201 of the ventilation tube 60 so that        both suction 440 and fluid delivery 525 orifice(s) are in fluid        communication to a proximal portion 774 of the interstitial        region that is proximal to width-expanded wiping element 588;    -   concurrent with a maintaining of the width-expanded wiping        element 588 in the width-expanded state, conveying negative        pressure from the suction source(s) 603, via the suction        lumen(s) 530 and orifice(s) 440, predominantly into the proximal        portion 774 of the interstitial region; and    -   concurrent with a maintaining of the width-expanded wiping        element 588 in the width-expanded state, sending fluid from the        fluid source(s) 602 through the fluid delivery orifice(s) 525        into the interstitial region proximal portion 774.        It is now disclosed a method of cleaning a main lumen of an ETT        or tracheostomy ventilation tube 60 and/or hindering        accumulation of biofilm on an inner surface of ventilation tube        60, the method comprising:

at a time when:

-   -   i. a ventilation machine 900 is connected to the ventilation        tube 60 via a tube connector assembly 158 in a substantially        air-tight manner;    -   ii. an elongate, flexible, main body 210 traverses an interior        of the tube connector assembly 158 so that a distal end of the        main body 210 is located within the ventilation tube 60 to form        an interstitial region outside of the main body 210 and within        the ventilator tube;    -   iii. a width-expandable wiping element 588 mounted to the main        body 210 is located within the ventilation tube 60;    -   iv. sources of fluid 602 and suction 603 are and are        respectively in fluid communication with fluid delivery        orifice(s) 525 and suction orifice(s) 440, the suction 440        orifice(s) being located proximal to wiping element 588 within        ventilation tube 60 and on main body 210 or mechanically coupled        to main body 210, carrying out the following:    -   a. expanding the mounted width-expandable wiping element 588        into contact with an inner surface 201 of the ventilation tube        60 so that both suction 440 and fluid delivery 525 orifice(s)        are in fluid

b. communication to a proximal portion 774 of the interstitial regionthat is proximal to width-expanded wiping element 588;

-   -   concurrent with a maintaining of the contact by the        width-expanded wiping element 588, conveying negative pressure        from the suction source(s) 603, via the suction lumen(s) 530 and        orifice(s) 440, predominantly into the proximal portion 774 of        the interstitial region; and    -   c. concurrent with a maintaining of the contact by the        width-expanded wiping element 588, sending fluid from the fluid        source(s) 602 through the fluid delivery orifice(s) 525 into the        interstitial region proximal portion 774.        In some embodiments, the suction source and/or the source of        fluid(s) are located outside of ventilation tube 60.        In some embodiments, further comprising moving the expanded        wiping element or inflated balloon in a longitudinal direction        so as to wipe material from the inner surface of ventilation        tube 60 and/or to hinder accumulation of biofilm thereon.        In some embodiments, the fluid which enters the proximal portion        774 includes a liquid.        In some embodiments, the fluid which enters the proximal portion        774 includes a mist.        In some embodiments, the fluid is sent into the interstitial        region proximal portion 774 so that a liquid-containing stream        of fluid flows therein, the fluid stream being sustained so that        a liquid fraction thereof flows at a flow rate of at least x        cc/second for at least y seconds, a value of x being at least        0.25 cc/second and a value of y being at least y seconds.        In some embodiments, x is at least 0.5 cc/second or at least 1        cc/second and/or at most 10 cc/second or at most 5 cc/second.        In some embodiments, carried out to deliver a mist into proximal        region 774.        In some embodiments, carried out to form a mist within        ventilation tube 60 which is formed within and/or delivered to        proximal region 774.        In some embodiments, fluid cannot be delivered into proximal        portion 774 when the balloon is not in contact with the inner        surface 201 of ventilation tube 60 and/or is in an uninflated        state.        In some embodiments, fluid cannot be delivered into proximal        portion 774 when the width-expandable wiping element is not in        contact with the inner surface 201 of ventilation tube 60 and/or        is in an unexpanded state.        In some embodiments, an inner surface of the ventilation tube is        cleaned within 15 second.        It is now disclosed a method of cleaning a main lumen of an ETT        or tracheostomy ventilation tube 60 comprising:

at a time when:

-   -   i. a ventilation machine 900 is connected to the ventilation        tube 60 via a tube connector assembly 158 in a substantially        air-tight manner;    -   ii. an elongate, flexible, main body 210 traverses an interior        of the tube connector assembly 158 so that a distal end of the        main body 210 is located within the ventilation tube 60 to form        an interstitial region outside of the main body 210 and within        the ventilator tube;    -   iii. a balloon 588 mounted to the main body 210 is located        within the ventilation tube 60;    -   iv. sources of pressurized fluid and/or suction 603 are:        -   A. any of which or both of which located in a            tube-connector-assembly-proximal location outside of the            ventilation tube 60 and proximal to tube connector assembly            158; and        -   B. are respectively in fluid communication with fluid            delivery orifice(s) 525 and suction orifice(s) 440 via fluid            delivery lumen(s) 520 and suction lumen(s) 530,    -   each of the suction 440 and fluid delivery 525 orifice(s) being:        -   A. located proximal to balloon 588 within ventilation tube            60, and        -   B. on main body 210 or mechanically coupled to main body            210, carrying out the following steps:    -   a. inflating the balloon 588 mounted to the main body 210 into        contact with an inner surface 201 of the ventilation tube 60 so        that both suction 440 and fluid delivery 525 orifice(s) are open        to a proximal portion 774 of the interstitial region that is        proximal to balloon 588;    -   b. concurrent with a maintaining of the contact by the balloon        588, forcing pressurized fluid from the pressurized fluid        source(s) 602 through the fluid delivery lumen(s) 520 and        orifice(s) 525, into the interstitial region proximal portion        774;    -   c. concurrent with a maintaining of the contact by the balloon        588, conveying negative pressure from the suction source(s) 603,        via the suction lumen(s) 530 and orifice(s) 440, predominantly        into the proximal portion 774 of the interstitial region.        It is now disclosed a ballooned cleaning device for use with an        ETT or tracheostomy ventilation tube 60, a ventilator machine        900, a source(s) of fluid (e.g. pressurized) and a source(s) of        suctioning 603, the cleaning device comprising:

a. a tube-connector assembly 158 for connecting the ventilation tube 60to the ventilator machine 900, in a substantially air-tight manner;

b. an elongate, flexible, main body 210 that is insertable through thetube-connector assembly 158 into the ventilation tube 60 to form aninterstitial region outside of the main body 210 within ventilation tube60;

c. a balloon 588 mounted to the main body 210 at a location (for examplein the distal half of the main body) and inflatable into contact with aninner surface 201 of the ventilation tube 60;

d. one or more fluid delivery lumen(s) 520 arranged within or along theelongated main body, and operative to transport pressurized fluidreceived from pressurized fluid source(s) outside of the ventilationtube 60, into a proximal portion 774 of the interstitial region that isproximal of the balloon 588 so that the transported fluid enters theproximal portion 774 via fluid delivery orifice(s) 525 located on ormechanically coupled to the main body 210;

e. suction lumen(s) 520 arranged within or along the main body, andoperative to convey negative pressure from suction source(s) 603predominantly into the proximal portion 774 of interstitial region viasuction orifice(s) 440 when balloon 588 is inflated into contact,suction orifice(s) 440 being open to the proximal portion 774 andmechanically coupled to the main body 210.

f. a suction port 820 connectable to the suction source(s) 603 formediating a connection between the suction source and the suctionlumen(s); and

g. a pliable sleeve 610 around at least a portion of the main body 210in locations proximal to the tube-connector assembly 158 and distal tothe suction port 820 to inhibit contamination.

In some embodiments, the balloon 588 is inflated by liquid or gassupplied by balloon fluid source that is located in thetube-assembly-proximal location.

In some embodiments, balloon 588 is supplied via a balloon lumen(s) 580that is different from fluid delivery lumen(s) 520.

In some embodiments, balloon 588 is inflated by gas or by a liquid.

In some embodiments, the fluid delivered via orifice(s) 525 and/or sentthrough fluid delivery lumen(s) 520 is a liquid and/or a liquid-gasmixture (e.g. a mist or bubbled fluid).

In some embodiments, balloon 588 is inflated by fluid (e.g. liquidand/or liquid-gas mixture) delivered via fluid delivery lumen(s) 520.

In some embodiments, a length of the pliable sleeve 610 is at least 5cm.

In some embodiments, the method is carried out when the suctionorifice(s) and/or the fluid delivery are located closer to balloon 588than to a proximal end 62 of ventilation tube 60.

In some embodiments, the method is carried out at a time when a pliablesleeve 610 is arranged around at least a portion of the main body 210 inlocations 598 proximal to the tube-connector assembly 158.

In some embodiments, the method is carried out at a time when a pliablesleeve 610 is arranged around at least a portion of the main body 210 inlocations 598 proximal to the tube-connector assembly and distal to asuction port 820 which mediates a connection between suction source(s)603 and suction lumen(s) 520.In some embodiments, the one or more suction orifice(s) is(are)longitudinally displaced from the balloon 588 by at most asuction-orifice-displacement-value that is at most 3 cm or at most 2 cmor at most 1 cm.

In some embodiments,

i. the pressurized fluid is simultaneously forced through first 525A andsecond 525B fluid delivery orifices to respectively produce first 556Aand second 556B fluid streams that are respectively and simultaneouslyincident upon an inner surface 201 of the ventilation tube 60 at first552A and second 552B locations; and

ii. the first 552A and second 552B locations are substantially onopposite sides of the ventilation tube 60 inner surface 201 within atolerance that is at most 75 degrees or at most 45 degrees or at most 25degrees.

In some embodiments, at least one fluid-delivery-orifice 525 isproximally displaced from the slidable boundary by at most afluid-orifice-displacement-value that is at most 3 cm, or at most 2 cmor at most 1 cm.

In some embodiments, the first 525A and second 525B fluid deliveryorifices are respectively supplied via first 520A and second 520Bfluid-delivery lumens.

In some embodiments, the first 520A and second 520B second fluiddelivery lumens are simultaneously supplied by a common pressurizedfluid chamber (e.g. a chamber mixing apparatus 696 of any otherchamber).

In some embodiments, immediately before exiting each fluid delivery port525, the delivered fluid is pressurized to at least 1.5 atmospheres, orat least 2 atmospheres or at least 3 atmospheres.

In some embodiments, each fluid delivery orifice 525 has a width of atmost 5 mm, at most 3 mm, or at most 2 mm, or at most 0.5 mm, at most 0.3mm, at most 0.2 mm.

In some embodiments, each fluid delivery orifice 525 has width that isat most 50%, or at most 25% or at most 10%, or at most 5%, of an averagewidth of the 440 suction orifice(s).

In some embodiments, the suction-orifice-displacement-value is at most 2cm, or at most 1 cm or at most 0.5 cm.

In some embodiments, the ventilation tube 60 is an ETT.

In some embodiments, the ventilation tube 60 is a tracheostomy tube.

In some embodiments, the fluid delivery operation and the suctioning arecarried out simultaneously.

In some embodiments, the fluid delivery operation and the suctioning arecarried out sequentially.

In some embodiments, concurrent to the maintaining of the slidableboundary, longitudinally moving

the boundary-forming balloon 588 so as to mechanically dislodge and/orloosen biofilm material located on the inner surface 201 of theventilation tube 60.

In some embodiments, the longitudinal moving is carried outsimultaneously with the fluid delivery operation and/or the suctioning.

In some embodiments, at least one of the fluid delivery orifice(s) 525are deployed to and/or voids within a second balloon 586 deployed distalto the boundary-forming balloon 588.

In some embodiments, the second balloon 586 is inflatable.

In some embodiments, the second balloon 586 is not inflatable.

In some embodiments, at least one of the at least one of the fluiddelivery orifice(s) 525 is an inner-surface-facing void in the main body210 facing towards the inner surface 201 of the ventilation tube 60 or ainner-surface-facing-void in a fluid-delivery lumen 520 that at leastspans a longitudinal range between the fluid delivery orifice(s) 525 anda location on or within the main body 210 that is proximal to theventilation tube connector assembly 158.

In some embodiments, i. at least one of the at least one of the fluiddelivery orifice(s) 525 is a void in the boundary-forming balloon 588 sothat the boundary-forming balloon 588 is leaky;

ii. forcing of pressurized fluid into the boundary-forming balloon 588is operative to carry out at least some of both of the balloon-inflationoperation and the fluid-delivery of the fluid-delivery operation.

In some embodiments, a surface of the boundary-forming balloon 588 is atleast 90% or at least, by surface area, substantially impermeable.

In some embodiments, a surface of the boundary-forming balloon 588 is atmost 99%, by surface area, substantially impermeable.

In some embodiments, boundary-forming 588 balloon is substantiallysealed and is not leaky.

In some embodiments, further comprising carrying out the additional stepof:

D. concurrent with the maintaining of the ventilation circuit, and at atime that the boundary-forming balloon 588 mounted to the elongate,flexible main body 210 is located within the ventilation tube 60 and ina non-obstructing mode so that the slidable boundary with the innersurface 201 of the ventilation tube 60 is not maintained and/or innon-contact mode so that balloon 588 is not inflated into contact withthe inner surface 201 of ventilation tube 60, proximally suctioning intothe suction orifice(s) 440 material that is located:

-   -   I. within the ventilation tube 60 and distal to the        boundary-forming balloon 588; and/or    -   II. distal to the ventilation tube distal end 60 so that the        material located distal to the ventilation tube distal end 60        enters an interior region of ventilation tube 60 en route to the        suction orifice(s),

wherein the suctioning step when the boundary-forming balloon 588 is innon-obstructing and/or non-contact mode is carried out to proximallytransport material suctioned in step D proximally out of ventilationtube 60 via a proximal opening of the ventilation tube 60.

In some embodiments, the balloon is mounted to the main body 210 at alocation in a distal half, or distal third, or distal quarter, or distalfifth or distal tenth of the main body 210.

In some embodiments, an inner diameter of ventilation tube 60 is atleast 4 mm and/or at most 11 mm.

In some embodiments, the pressurized fluid source 602 and the suctionsource 603 are respectively operative, in combination with the lumensand the orifices, to effect the fluid delivery and the suctioning whenthe boundary-forming balloon 588 is located in a distal half of theventilation tube 60 and/or the system lacks suction orifice(s) moredistal than the balloon 588.In some embodiments, the system lacks suction orifice(s) more distalthan the balloon 558 and/or distal to boundary and in fluidcommunication with suction source 603.In some embodiments, the combined total aperture area of any and allsuction orifices more distal than the balloon 588 and/or open to distallocations 778 is at most 50%, or at most 40%, or at most 30%, or at most20%, or at most 10% of the combined total aperture area of any and allsuction orifices 440 proximal to the balloon 558 and/or open to proximallocation(s) 774.In some embodiments, the combined total aperture area of any and allsuction orifices in fluid communication with suction source 603 and moredistal than the balloon 588 and/or open to distal locations 778 is atmost 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10%of the combined total aperture area of any and all suction orifices 440in fluid communication with suction source 603 and proximal to theballoon 558 and/or open to proximal location(s) 774.In some embodiments, further comprising: a sleeve 610 operative toenvelop and/or cover at least 5 cm of the elongate flexible main body210.In some embodiments, wherein a distal end of the sleeve 610 is directlyor indirectly attached to ventilation tube connector assembly 158 sothat the main body 210 may slide through the sleeve.In some embodiments, a proximal end of sleeve 610 is configured to havea substantially fixed longitudinal position relative to a proximal endof elongate flexible main body 210.In some embodiments, the system lacks suction orifice(s) more distalthan the balloon 558 and/or distal to boundary.

In some embodiments, the system lacks suction orifice(s) more distalthan the balloon 558 and/or distal to boundary and in fluidcommunication with suction source 603.

In some embodiments, wherein the combined total aperture area of any andall suction orifices more distal than the balloon 588 and/or open todistal locations 778 is at most 50%, or at most 40%, or at most 30%, orat most 20%, or at most 10% of the combined total aperture area of anyand all suction orifices 440 proximal to the balloon 558 and/or open toproximal location(s) 774.In some embodiments, the combined total aperture area of any and allsuction orifices in fluid communication with suction source 603 and moredistal than the balloon 588 and/or open to distal locations 778 is atmost 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10%of the combined total aperture area of any and all suction orifices 440in fluid communication with suction source 603 and proximal to theballoon 558 and/or open to proximal location(s) 774.In some embodiments, wherein at least one of the suction orifice(s) 440is in fluid communication, via suction lumen 520, with a blockingconstruct or blocking element that is distal of at least one suctionorifice 440 and that is configure to mostly or completely block fluidcommunication with a distal opening 519. 132. The device, system ormethod of any of preceding claim wherein the blocking construct orblocking element comprises a blocking glue or other material introducedonto or into suction lumen 520 and/or comprises a melt construct of amelted inner wall(s) of suction lumen(s) 520.In some embodiments, the system is operative such that:

i. the pressurized fluid is simultaneously forced through first 525A andsecond 525B fluid delivery orifices to respectively produce first 556Aand second 556B fluid streams that are respectively and simultaneouslyincident upon an inner surface 201 of the ventilation tube 60 at first552A and second 552B locations; and

ii. the first 552A and second 552B locations are substantially onopposite sides of the ventilation tube 60 inner surface 201 within atolerance that is at most 75 degrees.

In some embodiments, the system or apparatus comprises a plurality offluid delivery orifices 525 including:

i. a first fluid delivery orifice 525A deployed to a first side of theelongate main body 210; and

ii. a second fluid delivery orifice 525B deployed substantially to asecond side of the elongate main body 210 that is on opposite side ofmain body central axis 202 within a tolerance that is at most 75 degreesor at most 45 degrees or at most 25 degrees.

In some embodiments, the system or apparatus comprises first 525A andsecond 525B fluid delivery orifice(s) which are operative such that:

i. when an inner diameter of ventilation tube 60 is between 4 and 11 mmand exceeds an outer diameter of main body 210,

ii. when the main body 210 traverses the ventilation tube connector 158so as to enter the ventilation tube;

iii. when the boundary-forming balloon 588 is inflated so as to maintainthe boundary; and

iv. when the pressurized fluid is simultaneously forced, via fluiddelivery lumen(s) 530 through first 525A and second 525B fluid deliveryorifice,

to respectively produce first 556A and second 556B fluid streams thatare respectively and simultaneously incident upon an inner surface 201of the ventilation tube 60 at first 552A and second 552B locations suchthat the first 552A and second 552B locations are substantially onopposite sides of the ventilation tube 60 inner surface 201 within atolerance that is at most 75 degrees or at most 45 degrees or at most 25degrees.In some embodiments, at least one fluid-delivery-orifice 525 isproximally displaced from the slidable boundary by at most afluid-orifice-displacement-value that is at most 3 cm, or at most 2 cm.In some embodiments, the first 520A and second 520B fluid second fluiddelivery lumens are simultaneously supplied by a common pressurizedfluid chamber.In some embodiments, immediately before exiting each fluid delivery port525, the delivered fluid is pressurized to at least 1.5 atmospheres, orat least 2 atmospheres or at least 3 atmospheres.In some embodiments, one or more fluid delivery orifice 525, or amajority of the fluid delivery orifice(s) 525, has a width of at most 3mm, or at most 2 mm or at most 1 mm, or at most 0.5 mm, at most 0.3 mm,at most 0.2 mm and/or that is at most 50% or at most 25% or at most 10%or at most 5% of an average width of the 440 suction orifice(s).In some embodiments, the suction-orifice-displacement-value is at most 2cm, or at most 1 cm or at most 0.5 cm.In some embodiments, the main body 210 is operative to slidably, snuglyand/or internally traverse the connector assembly 158.

In some embodiments, i. negative pressure from suction source(s) 603induces air flow within the interstitial region; and

ii. the cleaning device provides a mode whereby a maximum rate of theinduced air flow within a distal portion 778 of the interstitial regiondistal to the inflatable balloon 588 is at most 20% of a maximum rate ofthe induced air flow in the proximal portion 774.

In some embodiments, all suction lumen(s) are collectively not in fluidcommunication with any suction orifice located distal to balloon 588.

In some embodiments,

i. collectively all suction lumen(s) of the cleaning device are in fluidcommunication with one or more proximal suction orifice(s) locatedproximal to balloon 588 and one or more distal orifice(s) located distalto balloon 588; and

ii. a ratio between an aggregate surface area of all proximal suctionorifice(s) 440 to an aggregate surface area of all distal suctionorifice(s) is at least SURF_AREA_RAT;

iii. a value of SURF_AREA_RAT is at least 1.5.

Although various embodiments were describe with respect to assembledsystems, it is appreciate that kits including one or more parts which,when assembled, form any presently disclosed apparatus or device orportion thereof are also in the scope of the invention. In differentnon-limiting examples, connector assembly 158 and/or input moduleassembly 156 and/or any port disclosed herein may be provided as partswhich may be assembled on-site (e.g. in the intensive care ward). Insome examples, sleeve 610 may be part of a kit and deployed on site.Other configurations are within the scope of embodiments of theinvention.

In the description and claims of the present application, each of theverbs, “comprise” “include” and “have”, and conjugates thereof, are usedto indicate that the object or objects of the verb are not necessarily acomplete listing of members, components, elements or parts of thesubject or subjects of the verb.

All references cited herein are incorporated by reference in theirentirety. Citation of a reference does not constitute an admission thatthe reference is prior art.

The articles “a” and “an” are used herein to refer to one or to morethan one (i.e., to at least one) of the grammatical object of thearticle. By way of example, “an element” means one element or more thanone element.

The term “including” is used herein to mean, and is used interchangeablywith, the phrase “including but not limited” to. The term “or” is usedherein to mean, and is used interchangeably with, the term “and/or,”unless context clearly indicates otherwise. The term “such as” is usedherein to mean, and is used interchangeably, with the phrase “such asbut not limited to”.

The present invention has been described using detailed descriptions ofembodiments thereof that are provided by way of example and are notintended to limit the scope of the invention. The described embodimentscomprise different features, not all of which are required in allembodiments of the invention. Some embodiments of the present inventionutilize only some of the features or possible combinations of thefeatures. Variations of embodiments of the present invention that aredescribed and embodiments of the present invention comprising differentcombinations of features noted in the described embodiments will occurto persons of the art.

What is claimed is:
 1. A wiping device for cleaning an inner surface ofa ventilation tube in a closed ventilation system where air ismechanically forced into the ventilation tube by an external ventilator,comprising: a ventilation tube connector assembly, an elongate flexiblemain body having a suction lumen and an inflation lumen, an inflatableballoon mounted to the elongate flexible main body at or near a distalend thereof, the inflatable balloon being sealed and expandable by fluidthrough the inflation lumen so that a balloon wall is brought intocontact with the ventilation tube inner surface when the main body isinserted inside the ventilation tube, one or more suction orifices onthe main body in fluid communication with the suction lumen, a pliableand impermeable sleeve around at least a portion of the main body, aninput module assembly connected to a proximal end of the main body, thepliable and impermeable sleeve being connected at a distal end to theventilation tube connector assembly, and at a proximal end to the inputmodule assembly, the input module assembly having: (i) a fluid sourcefor inflation of the inflatable balloon, the fluid source comprising agas delivered from a pressurized reservoir to the inflation lumen,wherein the fluid source is located within the input module assembly,(ii) a suction port connectable to a suction source, and (iii) aswitching assembly to manually regulate delivery of the gas from thefluid source in the input module assembly to the inflatable balloon andto regulate suction between the suction port and the suction lumen,wherein the switching assembly comprises a single or common switch whichregulates both delivery of gas from the fluid source to the inflatableballoon and suction through the suction lumen.
 2. The wiping device ofclaim 1, wherein the switching assembly comprises: (ii) a first switchto regulate delivery of gas from the fluid source to the inflatableballoon, and (iii) a second switch to regulate suction between thesuction port and the suction lumen.
 3. The wiping device of claim 2,wherein the first switch and second switch can be simultaneouslycontrolled.
 4. The wiping device of claim 2, wherein the first switch isbiased to an off position such there is no gas delivery for inflation ofthe inflatable balloon.
 5. The wiping device of claim 2, wherein thesecond switch is biased to an off position such there is no suctionthrough the suction lumen.
 6. The wiping device of claim 2, wherein thefirst switch is biased to an off position such there is no gas deliveryfor inflation of the inflatable balloon, and wherein the second switchis biased to an off position such there is no suction through thesuction lumen.
 7. The wiping device of claim 6, wherein the first switchand second switch can be simultaneously controlled.